FDA 510(k)

Surgical 3D Mask

Número K: K203565 · 2021-10-19

Data da decisão2021-10-19

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Surgical 3D Mask is the device name listed in this FDA 510(k) record. The listed applicant is Inno Lifecare. It received FDA 510(k) clearance on 2021-10-19 under 510(k) number K203565. 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 3D Mask?

Surgical 3D Mask is a medical device that received FDA 510(k) clearance on 2021-10-19. The listed applicant is Inno Lifecare. The 510(k) number is K203565.

When did Surgical 3D Mask receive FDA 510(k) clearance?

Surgical 3D Mask received FDA 510(k) clearance on 2021-10-19, under 510(k) number K203565.

Who is the listed applicant for Surgical 3D Mask?

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

What is the FDA product code for Surgical 3D Mask?

The FDA product code for Surgical 3D Mask is FXX.

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