FDA 510(k)

NeoGen PSR System

Número K: K221873 · 2023-01-12

Data da decisão2023-01-12

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

NeoGen PSR System is the device name listed in this FDA 510(k) record. The listed applicant is Energist Limited. It received FDA 510(k) clearance on 2023-01-12 under 510(k) number K221873. 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 NeoGen PSR System?

NeoGen PSR System is a medical device that received FDA 510(k) clearance on 2023-01-12. The listed applicant is Energist Limited. The 510(k) number is K221873.

When did NeoGen PSR System receive FDA 510(k) clearance?

NeoGen PSR System received FDA 510(k) clearance on 2023-01-12, under 510(k) number K221873.

Who is the listed applicant for NeoGen PSR System?

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

What is the FDA product code for NeoGen PSR System?

The FDA product code for NeoGen PSR System is GEI.

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