510(k) K243394

AF531 Oro-Nasal SE Face Mask by Respironics, Inc. — Product Code CBK

K243394 is an FDA 510(k) premarket notification submitted by Respironics, Inc. for the device "AF531 Oro-Nasal SE Face Mask". The FDA issued a decision of Substantially Equivalent on December 30, 2024. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Respironics, Inc. has at least 10 other 510(k) clearances on record.