The acquired K230073 file contains product-specific indications and users, design and operating principle, performance evidence actually described sections. Compare these dated manufacturer statements with your own indication and design before commissioning evidence work. They describe this submission; they do not prescribe your testing, validate performance independently or establish a suitable predicate.
Evidence retrieved 2026-10-07. Source versions and topic-specific limits are listed below.
Computed exact-code research
This decision beside its recorded product-code cohort
The 2021–2025 complete-year cohort contains 10 selected decisions under primary code GWQ. 10 have valid reported receipt/decision pairs; 0 pairs are missing or invalid.
No quartiles are displayed: this complete-year cohort has fewer than 20 valid pairs.
The table shows the named decision and up to four latest exact-code research records through 2026-09-27. It can include partial-year records outside the complete-year cohort. The quartiles above use the full stated cohort, not this displayed selection.
| Research record | Recorded device | Receipt → decision | Calendar elapsed days | Recorded submission type |
|---|
| K230073 ↗ · this page | Okti | 2023-01-10 → 2023-02-09 | 30 | Traditional |
|---|
| K261604 ↗ | Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32) | 2026-05-14 → 2026-06-13 | 30 | Special |
|---|
| K260455 ↗ | New Wave System | 2026-02-11 → 2026-03-13 | 30 | Special |
|---|
| K233403 ↗ | Flexset System | 2023-10-04 → 2024-04-30 | 209 | Traditional |
|---|
| K231366 ↗ | Neuronaute Plus | 2023-05-11 → 2023-11-09 | 182 | Traditional |
|---|
Use this comparison: select a record to investigate, read its actual indications and design, and document differences. A shared code or elapsed period cannot establish its relevance to your device.
Calendar elapsed days are not active FDA review time, a promised schedule or a success probability. The selection includes only the stated recorded decisions, not all applications. Latest records can postdate the named historical decision and are contextual research, not its predicates. Shared codes, summaries and observed records do not prove equivalence, current market availability, buyer applicability or predicate suitability.
Calculation, selection and source versions
Reuse the complete-endpoint exact-primary-code, documented SE-decision cohort and its stated cutoff/window. Retain its type-7 quartiles only when at least 20 valid date pairs are present. Independently subtract the named official record’s receipt date from its decision date; missing or negative pairs remain unknown. Show up to four latest exact-code research records, excluding the named ID. Parent analysis hash, source snapshots and calculation versions are retained.
Calculation: fda-named-decision-cohort-context-1; cutoff 2026-09-27; 0 parent records excluded; units record counts; calendar elapsed days.
Source snapshots: 5a86994ba49a37e71e09be96803fd51981c6c43eaa96caab41aea2b188bfe002.
Read beyond the decision row
Recorded evidence and differences to investigate
The summary is manufacturer-submitted context hosted by FDA. Negative/no-study statements are preserved. Evidence themes are not binding legal requirements.
Short opening excerpts identify the source sections. Read the linked original for the full study context, negative statements, tables and limitations. Public quotations are limited to 120 words per acquired summary; the internal evidence packet retains exact section ranges for review.
Indications and users
K230073 · PDF page 3 ↗ Source 2
The Okti System is intended for use in the recording, displaying, analysis, printing and storage of human biological
parameters such as heart and muscle activity, eye movement, breathing and body movements to assist in the diagnosis of
various neurological disorders.
The excerpt is shortened at a complete statement. Read the complete section in the original PDF before interpreting the evidence.
Compare with your product: Compare the recorded indication, population, body site and use environment with your proposed label. Record each change instead of assuming the primary code settles intended use.
Design and operating principle
K230073 · PDF page 5 ↗ Source 3
The Okti is a physiological data acquisition device intended for conducting EEG studies. It is used in
conjunction with a PC running Compumedics Profusion EEG software.
The excerpt is shortened at a complete statement. Read the complete section in the original PDF before interpreting the evidence.
Compare with your product: Compare physical design, materials, energy, accessories and operating principle with your design. Ask which documented differences change the evidence scope.
Performance evidence actually described
K230073 · PDF page 7 ↗ Source 4
An extensive collection of tests have been conducted and successfully completed including,
• Electrical Safety Testing as per IEC 60601-1:2005. These ensure there is no potential for
detrimental effects on patients, other persons, animals or the surroundings.The excerpt is shortened at a complete statement. Read the complete section in the original PDF before interpreting the evidence.
Compare with your product: The source labels this section as performance data. Determine which described evidence is bench, software, biological or clinical from the actual narrative and original tables; the section label alone does not settle that distinction or prescribe your testing.
Extraction selection and limits
Select observed whole-line section headings or explicit colon-delimited inline labels on readable PDF pages, including the explicitly documented heading-spacing variants in this parser version. Preserve the original heading, character ranges and layout; do not repair excerpt text. Exclude letter boilerplate and uncertain pages. Stop at observed table headings; do not infer table columns or scalar results from layout text. Multi-column or suspicious split-numeric excerpts are excluded until reviewed alternate extraction is available. Original layout records remain retained; any alternate text has its own extractor-version locator and requires original-page review. For each dimension, prefer usable versioned alternate text where available, selecting its longest usable excerpt; otherwise select the longest usable original-layout excerpt. Ties preserve source order. Bounded to 64 PDF pages and 3,500 characters per section. This is a selection, not a complete dossier analysis.
Excluded extraction items: {}.
Historical references beside dated FDA recognition metadata
Read each mention in the linked original summary, including statements that testing was not performed. Recognition metadata does not determine your testing needs, chosen edition or transition eligibility.
| Reference in this historical summary | Designation in the acquired FDA export | Recognition / entry date | Recorded transition-expiration date | Sources |
|---|
IEC 60601-1:2005
Summary of Performance Data | IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Note: This standard is recognized with relevant US national differences applied see references #1 and #2 in the Relevant FDA Guidance and/or Supportive Publication section below. | 19-49 · Complete
04/03/2023 | Not recorded in this export row | Summary [4] · Metadata [5]
Read scope and recognition limits ↗ |
IEC 60601-1-2
Summary of Performance Data | IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests | 19-36 · Partial
12/21/2020 | Not recorded in this export row | Summary [4] · Metadata [6]
Read scope and recognition limits ↗ |
IEC 60601-1-2
Summary of Performance Data | ANSI AAMI IEC 60601-1-2:2014 [Including AMD 1:2021]
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests [Including Amendment 1 (2021)] | 19-36 · Partial
12/21/2020 | Not recorded in this export row | Summary [4] · Metadata [7]
Read scope and recognition limits ↗ |
IEC 80601-2-26
Summary of Performance Data | IEC 80601-2-26 First Edition 2024-03 CONSOLIDATED VERSION
Medical electrical equipment -- Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs | 17-23 · Partial
05/25/2026 | Not recorded in this export row | Summary [4] · Metadata [8]
Read scope and recognition limits ↗ |
Prepare for your provider: the proposed protocol/report edition, its justification for your device and the complete current FDA recognition sheet. In particular, inspect exclusions for partial recognition. An edition difference does not automatically make the historical evidence unusable.
Identifier-matching method and selection limits
Match explicit ISO/IEC identifiers in selected preserved summary excerpts to the acquired, count-reconciled FDA metadata export. Preserve the historical edition mention, current snapshot designations, entry dates, recognition extent and any recorded transition-expiration date as separate facts. No title-similarity, edition-equivalence, test-mandate or transition-eligibility inference. At most twenty matched occurrences and thirty metadata rows per reference; wide matches are held for separate review.
3 of 3 matched reference occurrences shown.
