FDA 510(k)

Kangbeier Child Surgical Mask

Número K: K221753 · 2023-12-21

RequerenteXinxiang Kangbeier Medical Technology Co., Ltd.

Data da decisão2023-12-21

Código do produtoOXZ

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Kangbeier Child Surgical Mask 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 2023-12-21 under 510(k) number K221753. The device is classified under product code OXZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Kangbeier Child Surgical Mask?

Kangbeier Child Surgical Mask is a medical device that received FDA 510(k) clearance on 2023-12-21. The listed applicant is Xinxiang Kangbeier Medical Technology Co., Ltd.. The 510(k) number is K221753.

When did Kangbeier Child Surgical Mask receive FDA 510(k) clearance?

Kangbeier Child Surgical Mask received FDA 510(k) clearance on 2023-12-21, under 510(k) number K221753.

Who is the listed applicant for Kangbeier Child Surgical Mask?

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 Child Surgical Mask?

The FDA product code for Kangbeier Child Surgical Mask is OXZ.

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Outros registros que listam Xinxiang Kangbeier Medical Technology Co., Ltd. como candidato(a)

K213920Kangbeier Surgical Mask (Model: KBR-1001)

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