510(k) K234134

AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System by Resmed Pty Ltd (Registration Number: 3004604967) — Product Code BZD

K234134 is an FDA 510(k) premarket notification submitted by Resmed Pty Ltd (Registration Number: 3004604967) for the device "AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System". The FDA issued a decision of Substantially Equivalent on September 24, 2024. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905. Resmed Pty Ltd (Registration Number: 3004604967) has at least 2 other 510(k) clearances on record.