POSITIVE END EXPIRATORY PRESSURE VALVE— 510(k) K802943

Substantially Equivalent

Fraser Harlake, Inc.

FDA 510(k) clearance K802943 for POSITIVE END EXPIRATORY PRESSURE VALVE, Substantially Equivalent on 1981-01-15. Applicant: Fraser Harlake, Inc..

Clearance details

Applicant: Fraser Harlake, Inc.
Product code: Code BYE
Advisory panel: Anesthesiology
Date received: 1980-11-19
Decision date: 1981-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.