FDA 510(k)

DReal

K 號：K153519 · 2016-03-16

決定日期2016-03-16

產品代碼HBE

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

DReal is the device name listed in this FDA 510(k) record. The listed applicant is Carevature Medical, Ltd.. It received FDA 510(k) clearance on 2016-03-16 under 510(k) number K153519. The device is classified under product code HBE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DReal?

DReal is a medical device that received FDA 510(k) clearance on 2016-03-16. The listed applicant is Carevature Medical, Ltd.. The 510(k) number is K153519.

When did DReal receive FDA 510(k) clearance?

DReal received FDA 510(k) clearance on 2016-03-16, under 510(k) number K153519.

Who is the listed applicant for DReal?

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

What is the FDA product code for DReal?

The FDA product code for DReal is HBE.

相關器械（代碼：HBE）

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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：HBE）

官方來源