FDA 510(k)

Impertech Surgical Face Mask

Número K: K212046 · 2021-11-18

Data da decisão2021-11-18

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Impertech Surgical Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Impertech Industries , Ltd.. It received FDA 510(k) clearance on 2021-11-18 under 510(k) number K212046. 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 Impertech Surgical Face Mask?

Impertech Surgical Face Mask is a medical device that received FDA 510(k) clearance on 2021-11-18. The listed applicant is Impertech Industries , Ltd.. The 510(k) number is K212046.

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

Impertech Surgical Face Mask received FDA 510(k) clearance on 2021-11-18, under 510(k) number K212046.

Who is the listed applicant for Impertech Surgical Face Mask?

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

What is the FDA product code for Impertech Surgical Face Mask?

The FDA product code for Impertech Surgical Face Mask is FXX.

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