510(k) K233555

AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask by Philips Respironics — Product Code BZD

K233555 is an FDA 510(k) premarket notification submitted by Philips Respironics for the device "AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask". The FDA issued a decision of Substantially Equivalent on July 31, 2024. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905. Philips Respironics has at least 1 other 510(k) clearance on record.