POWERED EMERGENCY VENTILATOR— 510(k) K822040

Substantially Equivalent

Fraser Harlake, Inc.

FDA 510(k) clearance K822040 for POWERED EMERGENCY VENTILATOR, Substantially Equivalent on 1982-08-19. Applicant: Fraser Harlake, Inc..

Clearance details

Applicant: Fraser Harlake, Inc.
Product code: Code CBK
Advisory panel: Anesthesiology
Date received: 1982-07-12
Decision date: 1982-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Adverse events under product code CBK

product code CBK

Death: 736
Injury: 3,628
Malfunction: 98,786
Other: 4
Total: 103,154

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.