BATTERY PACKS— 510(k) K923305

Name: FDA 510(k) clearance K923305
Creator: U.S. Food and Drug Administration
Published: 1992-12-17

Substantially Equivalent

Access / God Loves You

FDA 510(k) clearance K923305 for BATTERY PACKS, Substantially Equivalent on 1992-12-17. Applicant: Access / God Loves You. Device class: 2.

Clearance details

Applicant: Access / God Loves You
Product code: Code CCK
Device class: Class 2
Regulation: 21 CFR 868.1400
Advisory panel: Anesthesiology
Date received: 1992-06-18
Decision date: 1992-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Castle Rock, CO, US

Download summary PDF View on FDA.gov ↗

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K250148 — Medical Gas Analyzer (AG200)2025-08-28
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More clearances from Access / God Loves You

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K931200 — BATTERY PACKS (VARIOUS MODELS)1993-07-13
K922910 — MEDICAL BATTERY PACKS1992-09-30
K922909 — MEDICAL BATTERY PACKS1992-09-23

Adverse events under product code CCK

product code CCK

Death: 3
Malfunction: 11,428
Total: 11,431

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.