MODIFIED OHMEDA PEEP VALVE (FOR GMS ABSORBER)— 510(k) K881614

Substantially Equivalent

Ohmeda Medical

FDA 510(k) clearance K881614 for MODIFIED OHMEDA PEEP VALVE (FOR GMS ABSORBER), Substantially Equivalent on 1988-04-29. Applicant: Ohmeda Medical.

Clearance details

Applicant: Ohmeda Medical
Product code: Code BYE
Advisory panel: Anesthesiology
Date received: 1988-04-12
Decision date: 1988-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Madison, WI, US

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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.