DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System

System, Imaging, Pulsed Doppler, Ultrasonic

Shenzhen Mindray Bio-Medical Electronics Co., LTD.

The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd. with the FDA for Dp-50/dp-50t/dp-50expert/dp-50s/dp-50pro Digital Ultrasonic Diagnostic Imaging System.

Pre-market Notification Details

Device IDK200979
510k NumberK200979
Device Name:DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Shenzhen Mindray Bio-Medical Electronics Co., LTD. Keji 12th Road South, Hi-tech Industrial Park Shenzhen,  CN 518057
ContactShi Jufang
CorrespondentShi Jufang
Shenzhen Mindray Bio-Medical Electronics Co., LTD. Keji 12th Road South, Hi-tech Industrial Park Shenzhen,  CN 518057
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-13
Decision Date2020-05-28

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