BARRIERFLEX-PF PULMONARY FUNCTION TESTING FILTER— 510(k) K934540

Substantially Equivalent

Bird Life Design

FDA 510(k) clearance K934540 for BARRIERFLEX-PF PULMONARY FUNCTION TESTING FILTER, Substantially Equivalent on 1993-10-19. Applicant: Bird Life Design.

Clearance details

Applicant: Bird Life Design
Product code: Code CAH
Advisory panel: Anesthesiology
Date received: 1993-09-16
Decision date: 1993-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

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Adverse events under product code CAH

product code CAH

Death: 7
Total: 7

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.