DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE FIXED PEEP VALVE— 510(k) K082092

Substantially Equivalent

Galemed Corp.

FDA 510(k) clearance K082092 for DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE FIXED PEEP VALVE, Substantially Equivalent on 2008-10-15. Applicant: Galemed Corp..

Clearance details

Applicant: Galemed Corp.
Product code: Code BTM
Advisory panel: Anesthesiology
Date received: 2008-07-24
Decision date: 2008-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, 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.