FDA 510(k)

COR12 ECG

Número K: K183369 · 2018-12-28

Data da decisão2018-12-28

Código do produtoDPS

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

COR12 ECG is the device name listed in this FDA 510(k) record. The listed applicant is Corscience GmbH & Co.. It received FDA 510(k) clearance on 2018-12-28 under 510(k) number K183369. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the COR12 ECG?

COR12 ECG is a medical device that received FDA 510(k) clearance on 2018-12-28. The listed applicant is Corscience GmbH & Co.. The 510(k) number is K183369.

When did COR12 ECG receive FDA 510(k) clearance?

COR12 ECG received FDA 510(k) clearance on 2018-12-28, under 510(k) number K183369.

Who is the listed applicant for COR12 ECG?

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

What is the FDA product code for COR12 ECG?

The FDA product code for COR12 ECG is DPS.

Dispositivos Relacionados (Código: DPS)

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