FDA 510(k)

3M Máscara Cirúrgica de Alto Desempenho, 3M Máscara Cirúrgica de Alto Desempenho com Protetor Facial

Número K: K180874 · 2018-07-31

Data da decisão2018-07-31

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield is the device name listed in this FDA 510(k) record. The listed applicant is 3M Healthcare. It received FDA 510(k) clearance on 2018-07-31 under 510(k) number K180874. 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 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield?

3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield is a medical device that received FDA 510(k) clearance on 2018-07-31. The listed applicant is 3M Healthcare. The 510(k) number is K180874.

When did 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield receive FDA 510(k) clearance?

3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield received FDA 510(k) clearance on 2018-07-31, under 510(k) number K180874.

Who is the listed applicant for 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield?

The FDA 510(k) record lists 3M Healthcare as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield?

The FDA product code for 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield is FXX.

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Outros registros que listam 3M Healthcare como candidato(a)

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Dispositivos Relacionados (Código: FXX)

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Fonte oficial

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