0-20 CM H20 PEEP VALVE— 510(k) K981415

Name: FDA 510(k) clearance K981415
Creator: U.S. Food and Drug Administration
Published: 1998-07-14

Substantially Equivalent

Cheen Houng Ent. Co. , Ltd.

FDA 510(k) clearance K981415 for 0-20 CM H20 PEEP VALVE, Substantially Equivalent on 1998-07-14. Applicant: Cheen Houng Ent. Co. , Ltd.. Device class: 2.

Clearance details

Applicant: Cheen Houng Ent. Co. , Ltd.
Product code: Code BYE
Device class: Class 2
Regulation: 21 CFR 868.5965
Advisory panel: Anesthesiology
Date received: 1998-04-20
Decision date: 1998-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei (Shulin), TW

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.