FDA 510(k)

Surgical Face Mask

Número K: K213617 · 2022-02-11

Data da decisão2022-02-11

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Surgical Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Megasoft (China) Co., Ltd.. It received FDA 510(k) clearance on 2022-02-11 under 510(k) number K213617. 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 Surgical Face Mask?

Surgical Face Mask is a medical device that received FDA 510(k) clearance on 2022-02-11. The listed applicant is Megasoft (China) Co., Ltd.. The 510(k) number is K213617.

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

Surgical Face Mask received FDA 510(k) clearance on 2022-02-11, under 510(k) number K213617.

Who is the listed applicant for Surgical Face Mask?

The FDA 510(k) record lists Megasoft (China) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Surgical Face Mask?

The FDA product code for Surgical Face Mask is FXX.

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