ZS3 And Z.one Pro Ultrasound Systems

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 Zs3 And Z.one Pro Ultrasound Systems.

Pre-market Notification Details

Device IDK192410
510k NumberK192410
Device Name:ZS3 And Z.one Pro Ultrasound Systems
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant ShenZhen Mindray Bio-Medical Electronics Co., Ltd Keji 12th Road South, High-tech Industrial Park, Shenzhen,  CN 518057
ContactJiang Haosen
CorrespondentJiang Haosen
ShenZhen Mindray Bio-Medical Electronics Co., Ltd Keji 12th Road South, High-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 Received2019-09-04
Decision Date2019-12-19

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06936415919382 K192410 000
06936415919375 K192410 000
06936415919368 K192410 000
06936415970888 K192410 000

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