FDA 510(k)

Procedure Mask, Surgical Mask

Número K: K213001 · 2022-05-11

Data da decisão2022-05-11

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Procedure Mask, Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is A Plus International, Inc.. It received FDA 510(k) clearance on 2022-05-11 under 510(k) number K213001. 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 Procedure Mask, Surgical Mask?

Procedure Mask, Surgical Mask is a medical device that received FDA 510(k) clearance on 2022-05-11. The listed applicant is A Plus International, Inc.. The 510(k) number is K213001.

When did Procedure Mask, Surgical Mask receive FDA 510(k) clearance?

Procedure Mask, Surgical Mask received FDA 510(k) clearance on 2022-05-11, under 510(k) number K213001.

Who is the listed applicant for Procedure Mask, Surgical Mask?

The FDA 510(k) record lists A Plus International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Procedure Mask, Surgical Mask?

The FDA product code for Procedure Mask, Surgical Mask is FXX.

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