Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa R9 Pro,Nuewa R9S,Resona 7,Resona 7CV,Resona 7EXP,Resona 7S, Resona 7OB,Resona 7PRO,Imagyn 7,Resona Y Diagnostic 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 Resona R9,resona R9 Exp,resona R9 Pro,resona R9s, Nuewa R9,nuewa R9 Exp,nuewa R9 Pro,nuewa R9s,resona 7,resona 7cv,resona 7exp,resona 7s, Resona 7ob,resona 7pro,imagyn 7,resona Y Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK202785
510k NumberK202785
Device Name:Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa R9 Pro,Nuewa R9S,Resona 7,Resona 7CV,Resona 7EXP,Resona 7S, Resona 7OB,Resona 7PRO,Imagyn 7,Resona Y Diagnostic 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
ContactMa Chao
CorrespondentMa Chao
Shenzhen Mindray Bio-Meidcal 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 Received2020-09-22
Decision Date2021-04-08

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