FDA 510(k)

CSMC Cardiac Suite

Número K: K172609 · 2017-11-03

Data da decisão2017-11-03

Código do produtoKPS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

CSMC Cardiac Suite is the device name listed in this FDA 510(k) record. The listed applicant is Cedars-Sinai Medical Center. It received FDA 510(k) clearance on 2017-11-03 under 510(k) number K172609. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CSMC Cardiac Suite?

CSMC Cardiac Suite is a medical device that received FDA 510(k) clearance on 2017-11-03. The listed applicant is Cedars-Sinai Medical Center. The 510(k) number is K172609.

When did CSMC Cardiac Suite receive FDA 510(k) clearance?

CSMC Cardiac Suite received FDA 510(k) clearance on 2017-11-03, under 510(k) number K172609.

Who is the listed applicant for CSMC Cardiac Suite?

The FDA 510(k) record lists Cedars-Sinai Medical Center as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CSMC Cardiac Suite?

The FDA product code for CSMC Cardiac Suite is KPS.

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