KEISEI— 510(k) K950613

Substantially Equivalent

Keisei (Usa) Co., Ltd.

FDA 510(k) clearance K950613 for KEISEI, Substantially Equivalent on 1996-02-14. Applicant: Keisei (Usa) Co., Ltd..

Clearance details

Applicant: Keisei (Usa) Co., Ltd.
Product code: Code CAE
Advisory panel: Anesthesiology
Date received: 1995-02-10
Decision date: 1996-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Torrance, CA, US

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Adverse events under product code CAE

product code CAE

Death: 4
Total: 4

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.