FDA 510(k)

CSMC 心臟套件

K 號：K172609 · 2017-11-03

決定日期2017-11-03

產品代碼KPS

諮詢委員會RA

決定相當於

器材摘要

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.

常見問題

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.

相關器械（代碼：KPS）

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官方來源

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：KPS）

官方來源