510(k) K241339

Besmed Bacterial Filter and HMEF by Besmed Health Business Corp — Product Code CAH

K241339 is an FDA 510(k) premarket notification submitted by Besmed Health Business Corp for the device "Besmed Bacterial Filter and HMEF". The FDA issued a decision of Substantially Equivalent on November 14, 2024. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Besmed Health Business Corp has at least 9 other 510(k) clearances on record.