FDA 510(k)

Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm))

Número K: K212460 · 2021-11-05

RequerenteGuangzhou Zhengkang Medical Equipment Co.,Ltd

Data da decisão2021-11-05

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm)) is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Zhengkang Medical Equipment Co.,Ltd. It received FDA 510(k) clearance on 2021-11-05 under 510(k) number K212460. 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 Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm))?

Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm)) is a medical device that received FDA 510(k) clearance on 2021-11-05. The listed applicant is Guangzhou Zhengkang Medical Equipment Co.,Ltd. The 510(k) number is K212460.

When did Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm)) receive FDA 510(k) clearance?

Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm)) received FDA 510(k) clearance on 2021-11-05, under 510(k) number K212460.

Who is the listed applicant for Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm))?

The FDA 510(k) record lists Guangzhou Zhengkang Medical Equipment Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm))?

The FDA product code for Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm)) is FXX.

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Outros registros que listam Guangzhou Zhengkang Medical Equipment Co.,Ltd como candidato(a)

K222204Medical Surgical Mask

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