BATTERY PACKS— 510(k) K923305

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.

Clearance details

Applicant: Access / God Loves You
Product code: Code CCK
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 ↗

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.