DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound 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 Dc-70/dc-70t/dc-70 Pro/dc-70 Exp/dc-75/dc-78/dc-70s Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK211337
510k NumberK211337
Device Name:DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound 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
ContactZhang Wei
CorrespondentZhang Wei
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
Subsequent Product CodeLLZ
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-03
Decision Date2021-07-01

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