ViewMate Multi Ultrasound System

System, Imaging, Pulsed Doppler, Ultrasonic

Shenzhen Mindray Bio-Meidcal Electronics Co., LTD

The following data is part of a premarket notification filed by Shenzhen Mindray Bio-meidcal Electronics Co., Ltd with the FDA for Viewmate Multi Ultrasound System.

Pre-market Notification Details

Device IDK222754
510k NumberK222754
Device Name:ViewMate Multi Ultrasound System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Shenzhen Mindray Bio-Meidcal Electronics Co., LTD Keji 12th Road South, Hi-tech Industrial Park Shenzhen,  CN 518057
ContactJin Jiahong
CorrespondentJin Jiahong
Shenzhen Mindray Bio-Meidcal 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 Received2022-09-12
Decision Date2022-11-09

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