FDA 510(k)

EasyInstruments

Número K: K182013 · 2019-03-11

RequerenteAgency For Medical Innovations GmbH

Data da decisão2019-03-11

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

EasyInstruments is the device name listed in this FDA 510(k) record. The listed applicant is Agency For Medical Innovations GmbH. It received FDA 510(k) clearance on 2019-03-11 under 510(k) number K182013. 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 EasyInstruments?

EasyInstruments is a medical device that received FDA 510(k) clearance on 2019-03-11. The listed applicant is Agency For Medical Innovations GmbH. The 510(k) number is K182013.

When did EasyInstruments receive FDA 510(k) clearance?

EasyInstruments received FDA 510(k) clearance on 2019-03-11, under 510(k) number K182013.

Who is the listed applicant for EasyInstruments?

The FDA 510(k) record lists Agency For Medical Innovations GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EasyInstruments?

The FDA product code for EasyInstruments is GEI.

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