FDA 510(k)

Medical Disposable Face Masks

Número K: K222809 · 2023-01-03

RequerenteAnqing Mayfield Medical Limited

Data da decisão2023-01-03

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Medical Disposable Face Masks is the device name listed in this FDA 510(k) record. The listed applicant is Anqing Mayfield Medical Limited. It received FDA 510(k) clearance on 2023-01-03 under 510(k) number K222809. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Medical Disposable Face Masks?

Medical Disposable Face Masks is a medical device that received FDA 510(k) clearance on 2023-01-03. The listed applicant is Anqing Mayfield Medical Limited. The 510(k) number is K222809.

When did Medical Disposable Face Masks receive FDA 510(k) clearance?

Medical Disposable Face Masks received FDA 510(k) clearance on 2023-01-03, under 510(k) number K222809.

Who is the listed applicant for Medical Disposable Face Masks?

The FDA 510(k) record lists Anqing Mayfield Medical Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medical Disposable Face Masks?

The FDA product code for Medical Disposable Face Masks is FXX.

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