FDA 510(k)

PLEXR PLUS

Número K: K210693 · 2022-03-22

Data da decisão2022-03-22

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

PLEXR PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Gmv S.R.L.. It received FDA 510(k) clearance on 2022-03-22 under 510(k) number K210693. 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 PLEXR PLUS?

PLEXR PLUS is a medical device that received FDA 510(k) clearance on 2022-03-22. The listed applicant is Gmv S.R.L.. The 510(k) number is K210693.

When did PLEXR PLUS receive FDA 510(k) clearance?

PLEXR PLUS received FDA 510(k) clearance on 2022-03-22, under 510(k) number K210693.

Who is the listed applicant for PLEXR PLUS?

The FDA 510(k) record lists Gmv S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PLEXR PLUS?

The FDA product code for PLEXR PLUS is GEI.

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