Ambu® Virobac II® Exhalation Filter
K-Number: K251583 · 2026-04-30
ApplicantAmbu A/S
Decision Date2026-04-30
Product CodeCAH
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
Ambu® Virobac II® Exhalation Filter is a medical device manufactured by Ambu A/S. It received FDA 510(k) clearance on 2026-04-30 under approval number K251583. The device is classified under product code CAH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Ambu® Virobac II® Exhalation Filter?
Ambu® Virobac II® Exhalation Filter is a medical device that received FDA 510(k) clearance on 2026-04-30. It is manufactured by Ambu A/S. The 510(k) number is K251583.
When was Ambu® Virobac II® Exhalation Filter approved by the FDA?
Ambu® Virobac II® Exhalation Filter received FDA 510(k) clearance on 2026-04-30, under approval number K251583.
What company makes Ambu® Virobac II® Exhalation Filter?
Ambu® Virobac II® Exhalation Filter is manufactured by Ambu A/S.
What is the FDA product code for Ambu® Virobac II® Exhalation Filter?
The FDA product code for Ambu® Virobac II® Exhalation Filter is CAH.
Related Devices (Code: CAH)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.