FDA 510(k)

Banyan USA Surgical Mask Level 3

Número K: K211097 · 2021-09-22

Data da decisão2021-09-22

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Banyan USA Surgical Mask Level 3 is the device name listed in this FDA 510(k) record. The listed applicant is Banyan USA, LLC. It received FDA 510(k) clearance on 2021-09-22 under 510(k) number K211097. 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 Banyan USA Surgical Mask Level 3?

Banyan USA Surgical Mask Level 3 is a medical device that received FDA 510(k) clearance on 2021-09-22. The listed applicant is Banyan USA, LLC. The 510(k) number is K211097.

When did Banyan USA Surgical Mask Level 3 receive FDA 510(k) clearance?

Banyan USA Surgical Mask Level 3 received FDA 510(k) clearance on 2021-09-22, under 510(k) number K211097.

Who is the listed applicant for Banyan USA Surgical Mask Level 3?

The FDA 510(k) record lists Banyan USA, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Banyan USA Surgical Mask Level 3?

The FDA product code for Banyan USA Surgical Mask Level 3 is FXX.

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