Ambu® Virobac II® Exhalation Filter— 510(k) K251583

Substantially Equivalent

Ambu A/S

FDA 510(k) clearance K251583 for Ambu® Virobac II® Exhalation Filter, Substantially Equivalent on 2026-04-30. Applicant: Ambu A/S.

Clearance details

Applicant: Ambu A/S
Product code: Code CAH
Advisory panel: Anesthesiology
Date received: 2025-05-23
Decision date: 2026-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ballerup, DK

Download summary PDF View on FDA.gov ↗

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.