DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80AExp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 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-90/dc-90s/dc-90q/dc-95/dc-95s/dc-88/dc-88s/dc-80a/dc-80aexp/dc-80a Pro/dc-8x/dc-8q/dc-81/dc-82 Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK201693
510k NumberK201693
Device Name:DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80AExp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Mindray Building, Keji 12th Road South Hi-tech Industrial Park Nanshan,  CN 518057
ContactZhang Wei
CorrespondentZhang Wei
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Mindray Building, Keji 12th Road South Hi-tech Industrial Park Nanshan,  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 Received2020-06-22
Decision Date2020-08-21

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