510(k) K251583

Ambu® Virobac II® Exhalation Filter by Ambu A/S — Product Code CAH

K251583 is an FDA 510(k) premarket notification submitted by Ambu A/S for the device "Ambu® Virobac II® Exhalation Filter". The FDA issued a decision of Substantially Equivalent on April 30, 2026. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Ambu A/S has at least 10 other 510(k) clearances on record.