Cruxi research & evidence
FDA 510(k) Submission Services evidence guides — page 102
Compare documented facts, dated analyses and evidence that can change your project scope. Confirm applicability with a specialist.
Compare FDA 510(k) Submission Services providers- Independent Corneal Viewing Chamber (IVC-21) (K211786): indications, design and recorded evidenceRegulatory decision evidence
- Index-Generating Electroencephalograph Software (OLW) — FDA decisions, comparisons and evidenceFDA record research
- Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep Care (K161458): indications, design and recorded evidenceRegulatory decision evidence
- Indicator, Physical/Chemical, Storage Temperature (OCI) — FDA decisions, comparisons and evidenceFDA record research
- Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) (K151845): indications, design and recorded evidenceRegulatory decision evidence
- Infant Positioner, Rx, Use In Highly Monitored Setting (OUW) — FDA decisions, comparisons and evidenceFDA record research
- Infant Transport Mattress Warmer with Disc (K163295): indications, design and recorded evidenceRegulatory decision evidence
- InferOperate Suite (K260973): indications, design and recorded evidenceRegulatory decision evidence
- InferRead CT Stroke.AI (K211179): indications, design and recorded evidenceRegulatory decision evidence
- InferRead Lung CT.AI (K240554): indications, design and recorded evidenceRegulatory decision evidence
- Infinity CentralStation Wide, Infinity M300, Infinity M300+ (K231477): indications, design and recorded evidenceRegulatory decision evidence
- Infinity® Acute Care System (IACS) VG8.1 (K260579): indications, design and recorded evidenceRegulatory decision evidence
- Influenza A And Influenza B Multiplex Nucleic Acid Assay (OZE) — FDA decisions, comparisons and evidenceFDA record research
- Influenza A Virus Subtype Differentiation Nucleic Acid Assay (OEP) — FDA decisions, comparisons and evidenceFDA record research
- Infrared Forehead Thermometer (K202420): indications, design and recorded evidenceRegulatory decision evidence
- Infrared Thermometer (model: E201) (K213011): indications, design and recorded evidenceRegulatory decision evidence
- Infrared thermometer, Models: YRK-002A, T8, T9, T10, T11 (K203662): indications, design and recorded evidenceRegulatory decision evidence
- Infrared thermometer, models KFT-22M, KFT-22, KFT-23, KFT-24, KFT-25, KFT-26, KFT-27, KFT-28 (K201600): indications, design and recorded evidenceRegulatory decision evidence
- Infrascanner Model 2500 (Model 2500) (K241389): indications, design and recorded evidenceRegulatory decision evidence
- Infusion Pump, Drug Specific, Pharmacy-Filled (QJY) — FDA decisions, comparisons and evidenceFDA record research
- Infusion Sets for Single Use (K202437): indications, design and recorded evidenceRegulatory decision evidence
- Infusomat® Space Volumetric Infusion Pump Administration Sets (K243392): indications, design and recorded evidenceRegulatory decision evidence
- Ingenix Spinal System (K241258): indications, design and recorded evidenceRegulatory decision evidence
- Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L) (K252247): indications, design and recorded evidenceRegulatory decision evidence
- Injector, Pen (NSC) — FDA decisions, comparisons and evidenceFDA record research
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