FDA 510(k)

TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System

K 號：K161525 · 2016-07-13

申請人Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

決定日期2016-07-13

產品代碼IYN

諮詢委員會RA

決定Substantially Equivalent

器材摘要

TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2016-07-13 under 510(k) number K161525. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System?

TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2016-07-13. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K161525.

When did TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System receive FDA 510(k) clearance?

TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System received FDA 510(k) clearance on 2016-07-13, under 510(k) number K161525.

Who is the listed applicant for TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System?

The FDA 510(k) record lists Shenzhen Mindray Bio-Medical Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System?

The FDA product code for TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System is IYN.

其他以 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. 為申請人之記錄

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。

查看所有 88 項裝置 →

相關器械（代碼：IYN）

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。

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。