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FDA 510(k)

Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM

Número K: K172457 · 2018-06-28

RequerenteDeltex Medical Limited
Data da decisão2018-06-28
Código do produtoDPW
Comité consultivoCV
DecisãoSubstantially Equivalent

Resumo do dispositivo

Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM is the device name listed in this FDA 510(k) record. The listed applicant is Deltex Medical Limited. It received FDA 510(k) clearance on 2018-06-28 under 510(k) number K172457. The device is classified under product code DPW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM?

Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM is a medical device that received FDA 510(k) clearance on 2018-06-28. The listed applicant is Deltex Medical Limited. The 510(k) number is K172457.

When did Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM receive FDA 510(k) clearance?

Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM received FDA 510(k) clearance on 2018-06-28, under 510(k) number K172457.

Who is the listed applicant for Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM?

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

What is the FDA product code for Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM?

The FDA product code for Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM is DPW.

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