FDA 510(k)

Máscara Cirúrgica PointCore

Número K: K220944 · 2022-09-09

Data da decisão2022-09-09

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

PointCore Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Pointcore, Inc.. It received FDA 510(k) clearance on 2022-09-09 under 510(k) number K220944. 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 PointCore Surgical Mask?

PointCore Surgical Mask is a medical device that received FDA 510(k) clearance on 2022-09-09. The listed applicant is Pointcore, Inc.. The 510(k) number is K220944.

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

PointCore Surgical Mask received FDA 510(k) clearance on 2022-09-09, under 510(k) number K220944.

Who is the listed applicant for PointCore Surgical Mask?

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

What is the FDA product code for PointCore Surgical Mask?

The FDA product code for PointCore Surgical Mask is FXX.

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