MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 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 Mx7/mx7t/vaus7/zeus/me7/anesus Me7/anesus Me7t/mx8/mx8t/vaus8/me8 Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK212900
510k NumberK212900
Device Name:MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 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
ContactShi Jufang
CorrespondentShi Jufang
Shenzhen Mindray Bio-Medical Electronics Co., LTD. Mindray Building, Keji 12th Road South, Hi-tech Industrial Park Nanshan, 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 Received2021-09-13
Decision Date2021-11-05

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.