AirFit F20 Mask System; AirFit F20 NM Mask System
K-Number: K242547 · 2025-05-19
ApplicantResmed Pty , Ltd.
Decision Date2025-05-19
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
AirFit F20 Mask System; AirFit F20 NM Mask System is a medical device manufactured by Resmed Pty , Ltd.. It received FDA 510(k) clearance on 2025-05-19 under approval number K242547. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the AirFit F20 Mask System; AirFit F20 NM Mask System?
AirFit F20 Mask System; AirFit F20 NM Mask System is a medical device that received FDA 510(k) clearance on 2025-05-19. It is manufactured by Resmed Pty , Ltd.. The 510(k) number is K242547.
When was AirFit F20 Mask System; AirFit F20 NM Mask System approved by the FDA?
AirFit F20 Mask System; AirFit F20 NM Mask System received FDA 510(k) clearance on 2025-05-19, under approval number K242547.
What company makes AirFit F20 Mask System; AirFit F20 NM Mask System?
AirFit F20 Mask System; AirFit F20 NM Mask System is manufactured by Resmed Pty , Ltd..
What is the FDA product code for AirFit F20 Mask System; AirFit F20 NM Mask System?
The FDA product code for AirFit F20 Mask System; AirFit F20 NM Mask System is BZD.
Related Clinical Trials
Other Devices by Resmed Pty , Ltd.
Related Devices (Code: BZD)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.