FDA 510(k)

Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile)

Número K: K202843 · 2021-01-12

RequerenteB.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.

Data da decisão2021-01-12

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile) is the device name listed in this FDA 510(k) record. The listed applicant is B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.. It received FDA 510(k) clearance on 2021-01-12 under 510(k) number K202843. 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 Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile)?

Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile) is a medical device that received FDA 510(k) clearance on 2021-01-12. The listed applicant is B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.. The 510(k) number is K202843.

When did Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile) receive FDA 510(k) clearance?

Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile) received FDA 510(k) clearance on 2021-01-12, under 510(k) number K202843.

Who is the listed applicant for Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile)?

The FDA 510(k) record lists B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile)?

The FDA product code for Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile) is FXX.

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Outros registros que listam B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. como candidato(a)

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Dispositivos Relacionados (Código: FXX)

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