Cruxi research & evidence
FDA 510(k) Submission Services evidence guides — page 94
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- ICS Dizcovery (1091) (K242198): indications, design and recorded evidenceRegulatory decision evidence
- ID-Cap System (K183052): indications, design and recorded evidenceRegulatory decision evidence
- IDC INTERLOCKING DETACHABLE COIL (K141378): indications, design and recorded evidenceRegulatory decision evidence
- IDEAL Ziploop (K233552): indications, design and recorded evidenceRegulatory decision evidence
- IDENTIFY (K230576): indications, design and recorded evidenceRegulatory decision evidence
- IDS SHBG (K190121): indications, design and recorded evidenceRegulatory decision evidence
- IEC 60086-5 Edition 5.0 2021-09 — FDA recognition transition and report handoffCompliance research
- IEC 60601-2-10 Edition 2.2 2023-01 CONSOLIDATED VERSION — FDA recognition transition and report handoffCompliance research
- IEC 60601-2-2 Edition 6.1 2023-02 CONSOLIDATED VERSION Corrected Version 2025-11 — FDA recognition transition and report handoffCompliance research
- IEC 60601-2-22 Edition 4.0 2019-11 — FDA recognition transition and report handoffCompliance research
- IEC 60601-2-34 Edition 4.0 2024-10 — FDA recognition transition and report handoffCompliance research
- IEC 60601-2-37 Edition 3.0 2024-07 — FDA recognition transition and report handoffCompliance research
- IEC 60601-2-57 Edition 2.0 2023-07 — FDA recognition transition and report handoffCompliance research
- IEC 60601-2-68 Edition 2.0 2025-02 — FDA recognition transition and report handoffCompliance research
- IEC 61326-2-6 Edition 4.0 2025-06 — FDA recognition transition and report handoffCompliance research
- IEC 61674 Edition 3.0 2024-07 — FDA recognition transition and report handoffCompliance research
- IEC 61689 Edition 4.0 2022-03 — FDA recognition transition and report handoffCompliance research
- IEC 62127-03 Edition 2.0 2022-12 — FDA recognition transition and report handoffCompliance research
- IEC 62127-2 Edition 2.0 2025-01 — FDA recognition transition and report handoffCompliance research
- IEC 62133-2 Edition 1.1 2021-07 CONSOLIDATED VERSION — FDA recognition transition and report handoffCompliance research
- IEC 80601-2-58 Edition 3.0 2024-03; ANSI AAMI IEC 80601-2-58:2024 — FDA recognition transition and report handoffCompliance research
- IEC 80601-2-59 Edition 2.1 2023-01 CONSOLIDATED VERSION — FDA recognition transition and report handoffCompliance research
- IEC 80601-2-77 Edition 1.1 2023-11 CONSOLIDATED VERSION — FDA recognition transition and report handoffCompliance research
- IEC TS 60601-4-2 Edition 1.0 2024-03 — FDA recognition transition and report handoffCompliance research
- IEEE Std 11073-10101b-2023 — FDA recognition transition and report handoffCompliance research
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