FDA 510(k)

CARESCAPE Central Station V2

K 號：K162012 · 2016-09-15

決定日期2016-09-15

產品代碼DXJ

諮詢委員會CV

決定Substantially Equivalent

器材摘要

CARESCAPE Central Station V2 is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare. It received FDA 510(k) clearance on 2016-09-15 under 510(k) number K162012. The device is classified under product code DXJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CARESCAPE Central Station V2?

CARESCAPE Central Station V2 is a medical device that received FDA 510(k) clearance on 2016-09-15. The listed applicant is GE Healthcare. The 510(k) number is K162012.

When did CARESCAPE Central Station V2 receive FDA 510(k) clearance?

CARESCAPE Central Station V2 received FDA 510(k) clearance on 2016-09-15, under 510(k) number K162012.

Who is the listed applicant for CARESCAPE Central Station V2?

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

What is the FDA product code for CARESCAPE Central Station V2?

The FDA product code for CARESCAPE Central Station V2 is DXJ.

其他以 GE Healthcare 為申請人之記錄

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相關器械（代碼：DXJ）

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。

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官方來源

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