FDA 510(k)

Máscara Nordiwell Surprotect

Número K: K210445 · 2021-06-29

RequerenteChangzhou Combat Protective Equipment Co., Ltd.

Data da decisão2021-06-29

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Nordiwell Surprotect Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Combat Protective Equipment Co., Ltd.. It received FDA 510(k) clearance on 2021-06-29 under 510(k) number K210445. 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 Nordiwell Surprotect Face Mask?

Nordiwell Surprotect Face Mask is a medical device that received FDA 510(k) clearance on 2021-06-29. The listed applicant is Changzhou Combat Protective Equipment Co., Ltd.. The 510(k) number is K210445.

When did Nordiwell Surprotect Face Mask receive FDA 510(k) clearance?

Nordiwell Surprotect Face Mask received FDA 510(k) clearance on 2021-06-29, under 510(k) number K210445.

Who is the listed applicant for Nordiwell Surprotect Face Mask?

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

What is the FDA product code for Nordiwell Surprotect Face Mask?

The FDA product code for Nordiwell Surprotect Face Mask is FXX.

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Outros registros que listam Changzhou Combat Protective Equipment Co., Ltd. como candidato(a)

K210181Nordiwell Surgical Face Mask K202615Nordiwell Medical Face Mask

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Fonte oficial

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