FDA 510(k)

Sistema de Máscara AirFit F20; Sistema de Máscara AirFit F20 NM

Número K: K242547 · 2025-05-19

Data da decisão2025-05-19

Código do produtoBZD

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Outros registros que listam Resmed Pty , Ltd. como candidato(a)

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Dispositivos Relacionados (Código: BZD)

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Fonte oficial

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