Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous

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 Hepatus 7/hepatus 6/hepatus 5/hepatus 7s/hepatus 6s/hepatus 5s/hepatus 7t/hepatus 6t/hepatus 5t/fibrous 7/fibrous.

Pre-market Notification Details

Device IDK200643
510k NumberK200643
Device Name:Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Shenzhen Mindray Bio-Medical Electronics Co., LTD Keji 12th Road South, Hi-tech Industrial Park Shenzhen,  CN 518057
ContactJiang Xiaoyong
CorrespondentJiang Xiaoyong
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 Received2020-03-11
Decision Date2020-07-24

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