Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02— 510(k) K003927

Name: FDA 510(k) clearance K003927
Creator: U.S. Food and Drug Administration
Published: 2001-06-26

Substantially Equivalent

Cheen Houng Ent. Co. , Ltd.

FDA 510(k) clearance K003927 for Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02, Substantially Equivalent on 2001-06-26. Applicant: Cheen Houng Ent. Co. , Ltd.. Device class: 2.

Clearance details

Applicant: Cheen Houng Ent. Co. , Ltd.
Product code: Code BTM
Device class: Class 2
Regulation: 21 CFR 868.5915
Advisory panel: Anesthesiology
Date received: 2000-12-20
Decision date: 2001-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei (Shulin), TW

Download summary PDF View on FDA.gov ↗

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K970688 — POCKET RESCUE1997-09-26

Adverse events under product code BTM

product code BTM

Death: 19
Other: 2
Total: 21

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.