FDA 510(k)

Disposable Procedural Ear-loop Face Mask

Número K: K211042 · 2021-07-15

RequerenteChangzhou Dsb Medical Co., Ltd.

Data da decisão2021-07-15

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Disposable Procedural Ear-loop Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Dsb Medical Co., Ltd.. It received FDA 510(k) clearance on 2021-07-15 under 510(k) number K211042. 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 Disposable Procedural Ear-loop Face Mask?

Disposable Procedural Ear-loop Face Mask is a medical device that received FDA 510(k) clearance on 2021-07-15. The listed applicant is Changzhou Dsb Medical Co., Ltd.. The 510(k) number is K211042.

When did Disposable Procedural Ear-loop Face Mask receive FDA 510(k) clearance?

Disposable Procedural Ear-loop Face Mask received FDA 510(k) clearance on 2021-07-15, under 510(k) number K211042.

Who is the listed applicant for Disposable Procedural Ear-loop Face Mask?

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

What is the FDA product code for Disposable Procedural Ear-loop Face Mask?

The FDA product code for Disposable Procedural Ear-loop Face Mask is FXX.

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