FDA 510(k)

Kangbeier Surgical Mask (Model: KBR-1001)

Número K: K213920 · 2022-01-16

RequerenteXinxiang Kangbeier Medical Technology Co., Ltd.

Data da decisão2022-01-16

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Kangbeier Surgical Mask (Model: KBR-1001) is the device name listed in this FDA 510(k) record. The listed applicant is Xinxiang Kangbeier Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-01-16 under 510(k) number K213920. 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 Kangbeier Surgical Mask (Model: KBR-1001)?

Kangbeier Surgical Mask (Model: KBR-1001) is a medical device that received FDA 510(k) clearance on 2022-01-16. The listed applicant is Xinxiang Kangbeier Medical Technology Co., Ltd.. The 510(k) number is K213920.

When did Kangbeier Surgical Mask (Model: KBR-1001) receive FDA 510(k) clearance?

Kangbeier Surgical Mask (Model: KBR-1001) received FDA 510(k) clearance on 2022-01-16, under 510(k) number K213920.

Who is the listed applicant for Kangbeier Surgical Mask (Model: KBR-1001)?

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

What is the FDA product code for Kangbeier Surgical Mask (Model: KBR-1001)?

The FDA product code for Kangbeier Surgical Mask (Model: KBR-1001) is FXX.

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