FDA 510(k)

Cerebrotech CMS-5000

K 號：K171186 · 2017-12-08

決定日期2017-12-08

產品代碼QAF

諮詢委員會履歷

決定相當於

器材摘要

Cerebrotech CMS-5000 is the device name listed in this FDA 510(k) record. The listed applicant is Cerebrotech Medical Systems. It received FDA 510(k) clearance on 2017-12-08 under 510(k) number K171186. The device is classified under product code QAF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Cerebrotech CMS-5000?

Cerebrotech CMS-5000 is a medical device that received FDA 510(k) clearance on 2017-12-08. The listed applicant is Cerebrotech Medical Systems. The 510(k) number is K171186.

When did Cerebrotech CMS-5000 receive FDA 510(k) clearance?

Cerebrotech CMS-5000 received FDA 510(k) clearance on 2017-12-08, under 510(k) number K171186.

Who is the listed applicant for Cerebrotech CMS-5000?

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

What is the FDA product code for Cerebrotech CMS-5000?

The FDA product code for Cerebrotech CMS-5000 is QAF.

相關器械（代碼：QAF）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K253840STEDI 扫描設備Stroke DX K182967視覺系統Cerebrotech Medical Systems, Inc.

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：QAF）

官方來源