Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI, Consona NT, Nuewa N9, Recho N9, Consona N9 Exp, Consona N9 Elite, Resona N9, Consona N9T, Consona N8, Consona N8 Pro, Consona N8 Super, Consona OR, Consona N8S, Cons

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 Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9s, Consona Ni, Consona Nt, Nuewa N9, Recho N9, Consona N9 Exp, Consona N9 Elite, Resona N9, Consona N9t, Consona N8, Consona N8 Pro, Consona N8 Super, Consona Or, Consona N8s, Cons.

Pre-market Notification Details

Device IDK221300
510k NumberK221300
Device Name:Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI, Consona NT, Nuewa N9, Recho N9, Consona N9 Exp, Consona N9 Elite, Resona N9, Consona N9T, Consona N8, Consona N8 Pro, Consona N8 Super, Consona OR, Consona N8S, Cons
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Shenzhen Mindray Bio-Medical Electronics Co.,LTD Keji 12th Road South, Hi-tech Industrial Park Shenzhen,  CN 518057
ContactZhang Wei
CorrespondentZhang Wei
Shenzhen Mindray Bio-Medical 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 Received2022-05-05
Decision Date2022-09-29

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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