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

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..

Clearance details

Applicant: Cheen Houng Ent. Co. , Ltd.
Product code: Code BTM
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 ↗

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.