FDA 510(k)

EMMa Electronic Monitoring Management

Número K: K153477 · 2016-05-25

Data da decisão2016-05-25

Código do produtoDSI

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

EMMa Electronic Monitoring Management is the device name listed in this FDA 510(k) record. The listed applicant is Vitasystems GmbH. It received FDA 510(k) clearance on 2016-05-25 under 510(k) number K153477. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the EMMa Electronic Monitoring Management?

EMMa Electronic Monitoring Management is a medical device that received FDA 510(k) clearance on 2016-05-25. The listed applicant is Vitasystems GmbH. The 510(k) number is K153477.

When did EMMa Electronic Monitoring Management receive FDA 510(k) clearance?

EMMa Electronic Monitoring Management received FDA 510(k) clearance on 2016-05-25, under 510(k) number K153477.

Who is the listed applicant for EMMa Electronic Monitoring Management?

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

What is the FDA product code for EMMa Electronic Monitoring Management?

The FDA product code for EMMa Electronic Monitoring Management is DSI.

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