FDA 510(k)

Plasmage System

Número K: K202106 · 2022-04-06

Data da decisão2022-04-06

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Plasmage System is the device name listed in this FDA 510(k) record. The listed applicant is Brera Medical, Inc.. It received FDA 510(k) clearance on 2022-04-06 under 510(k) number K202106. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Plasmage System?

Plasmage System is a medical device that received FDA 510(k) clearance on 2022-04-06. The listed applicant is Brera Medical, Inc.. The 510(k) number is K202106.

When did Plasmage System receive FDA 510(k) clearance?

Plasmage System received FDA 510(k) clearance on 2022-04-06, under 510(k) number K202106.

Who is the listed applicant for Plasmage System?

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

What is the FDA product code for Plasmage System?

The FDA product code for Plasmage System is GEI.

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