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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Resmed Pty , Ltd.. It received FDA 510(k) clearance on 2025-05-19 under 510(k) 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. The listed applicant is Resmed Pty , Ltd.. The 510(k) number is K242547.

When did AirFit F20 Mask System; AirFit F20 NM Mask System receive FDA 510(k) clearance?

AirFit F20 Mask System; AirFit F20 NM Mask System received FDA 510(k) clearance on 2025-05-19, under 510(k) number K242547.

Who is the listed applicant for AirFit F20 Mask System; AirFit F20 NM Mask System?

The FDA 510(k) record lists Resmed Pty , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Resmed Pty , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251661Mariana Minerva; Mariana NimbusK203126S10 Kirra

Related Devices (Code: BZD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253044RXiBreeze PAP System (RXiBreeze 20C)Resvent Medical Technology Co., Ltd.K253553OrionResmed CorpK254104ResScan EssentialsResmed CorpK251920Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face MaskDcstar, Inc.K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical Co., Ltd.K252338MySleepDashSomnetics International, Inc. (Dba Transcend Inc)

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.

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