LIFE ISLAND 21— 510(k) K925651

Name: FDA 510(k) clearance K925651
Creator: U.S. Food and Drug Administration
Published: 1993-07-27

Substantially Equivalent

Keisei (Usa) Co., Ltd.

FDA 510(k) clearance K925651 for LIFE ISLAND 21, Substantially Equivalent on 1993-07-27. Applicant: Keisei (Usa) Co., Ltd.. Device class: 2.

Clearance details

Applicant: Keisei (Usa) Co., Ltd.
Product code: Code FNM
Device class: Class 2
Regulation: 21 CFR 880.5550
Advisory panel: General Hospital
Date received: 1992-11-09
Decision date: 1993-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Torrance, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FNM

product code FNM

Death: 22
Injury: 349
Other: 4
Total: 375

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.