OEMEDIC INTERNATIONAL INC. BESMED SILICONE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK AND RESERVOIR— 510(k) K021446

Substantially Equivalent

Oemedic International, Inc.

FDA 510(k) clearance K021446 for OEMEDIC INTERNATIONAL INC. BESMED SILICONE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK AND RESERVOIR, Substantially Equivalent on 2002-10-11. Applicant: Oemedic International, Inc..

Clearance details

Applicant: Oemedic International, Inc.
Product code: Code BTM
Advisory panel: Anesthesiology
Date received: 2002-05-06
Decision date: 2002-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Littleton, CO, US

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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.