FDA 510(k)

3M® VFlex® Health Care Particulate Respirator and Surgical Mask, Models 1804/1804S

Número K: K171116 · 2017-08-10

Data da decisão2017-08-10

Código do produtoMSH

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S is the device name listed in this FDA 510(k) record. The listed applicant is 3M Healthcare. It received FDA 510(k) clearance on 2017-08-10 under 510(k) number K171116. The device is classified under product code MSH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the 3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S?

3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S is a medical device that received FDA 510(k) clearance on 2017-08-10. The listed applicant is 3M Healthcare. The 510(k) number is K171116.

When did 3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S receive FDA 510(k) clearance?

3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S received FDA 510(k) clearance on 2017-08-10, under 510(k) number K171116.

Who is the listed applicant for 3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S?

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™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S?

The FDA product code for 3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S is MSH.

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