FDA 510(k)

全數位彩色多普勒超聲診斷系統

K 號：K183041 · 2019-07-10

申請人Wuhan Zoncare Bio-medical Electronics Co., Ltd.

決定日期2019-07-10

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

Full Digital Colour Doppler Ultrasonic Diagnostic System is the device name listed in this FDA 510(k) record. The listed applicant is Wuhan Zoncare Bio-medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2019-07-10 under 510(k) number K183041. 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 Full Digital Colour Doppler Ultrasonic Diagnostic System?

Full Digital Colour Doppler Ultrasonic Diagnostic System is a medical device that received FDA 510(k) clearance on 2019-07-10. The listed applicant is Wuhan Zoncare Bio-medical Electronics Co., Ltd.. The 510(k) number is K183041.

When did Full Digital Colour Doppler Ultrasonic Diagnostic System receive FDA 510(k) clearance?

Full Digital Colour Doppler Ultrasonic Diagnostic System received FDA 510(k) clearance on 2019-07-10, under 510(k) number K183041.

Who is the listed applicant for Full Digital Colour Doppler Ultrasonic Diagnostic System?

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

What is the FDA product code for Full Digital Colour Doppler Ultrasonic Diagnostic System?

The FDA product code for Full Digital Colour Doppler Ultrasonic Diagnostic System is IYN.

相關器械（代碼：IYN）

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：IYN）

官方來源