FDA 510(k)

Single-Use Surgical Mask

Número K: K201924 · 2021-03-15

RequerenteQiqihar Hengxin Medical Supplies, Ltd.

Data da decisão2021-03-15

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Single-Use Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Qiqihar Hengxin Medical Supplies, Ltd.. It received FDA 510(k) clearance on 2021-03-15 under 510(k) number K201924. 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 Single-Use Surgical Mask?

Single-Use Surgical Mask is a medical device that received FDA 510(k) clearance on 2021-03-15. The listed applicant is Qiqihar Hengxin Medical Supplies, Ltd.. The 510(k) number is K201924.

When did Single-Use Surgical Mask receive FDA 510(k) clearance?

Single-Use Surgical Mask received FDA 510(k) clearance on 2021-03-15, under 510(k) number K201924.

Who is the listed applicant for Single-Use Surgical Mask?

The FDA 510(k) record lists Qiqihar Hengxin Medical Supplies, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single-Use Surgical Mask?

The FDA product code for Single-Use Surgical Mask is FXX.

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Outros registros que listam Qiqihar Hengxin Medical Supplies, Ltd. como candidato(a)

K201691Single-Use Surgical Mask With Ear Loop

Dispositivos Relacionados (Código: FXX)

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