510(k) K230483

Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) by Passy-Muir, Inc. — Product Code CAH

K230483 is an FDA 510(k) premarket notification submitted by Passy-Muir, Inc. for the device "Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)". The FDA issued a decision of Substantially Equivalent on September 16, 2023. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Passy-Muir, Inc. has at least 4 other 510(k) clearances on record.