SYSTEM 22 VALVE— 510(k) K950397

Name: FDA 510(k) clearance K950397
Creator: U.S. Food and Drug Administration
Published: 1995-04-14

Substantially Equivalent

Turnkey Intergration USA, Inc.

FDA 510(k) clearance K950397 for SYSTEM 22 VALVE, Substantially Equivalent on 1995-04-14. Applicant: Turnkey Intergration USA, Inc.. Device class: 2.

Clearance details

Applicant: Turnkey Intergration USA, Inc.
Product code: Code BYE
Device class: Class 2
Regulation: 21 CFR 868.5965
Advisory panel: Anesthesiology
Date received: 1995-02-01
Decision date: 1995-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code BYE

product code BYE

Death: 5
Total: 5

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.