FDA 510(k)

Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB 識別超音波系統

K 號：K171233 · 2017-09-12

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

決定日期2017-09-12

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.. It received FDA 510(k) clearance on 2017-09-12 under 510(k) number K171233. 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 Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System?

Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2017-09-12. The listed applicant is Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.. The 510(k) number is K171233.

When did Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System receive FDA 510(k) clearance?

Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System received FDA 510(k) clearance on 2017-09-12, under 510(k) number K171233.

Who is the listed applicant for Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System?

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

What is the FDA product code for Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System?

The FDA product code for Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System is IYN.

其他以 Shenzhen Mindray Bio-Meidcal 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。

K221267VS 8 項生命徵監測儀，VS 8A 項生命徵監測儀，VS 9 項生命徵監測儀 K222754ViewMate多超聲系統 K202785Resona R9、Resona R9 Exp、Resona R9 Pro、Resona R9S、Nuewa R9、Nuewa R9 Exp、Nuewa R9 Pro、Nuewa R9S、Resona 7、Resona 7CV、Resona 7EXP、Resona 7S、Resona 7OB、Resona 7PRO、Imagyn 7、Resona Y 診斷超音波系統 K173369DC-30/DC-32/DC-28/DC-26/DC-25 診斷超音波系統 K170712Accutorr 7/VS-900 Vital Signs Monitor

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。