VINNO 8, VINNO 6, VINNO 5

System, Imaging, Pulsed Doppler, Ultrasonic

VINNO Technology (Suzhou) Co., Ltd.

The following data is part of a premarket notification filed by Vinno Technology (suzhou) Co., Ltd. with the FDA for Vinno 8, Vinno 6, Vinno 5.

Pre-market Notification Details

Device IDK190120
510k NumberK190120
Device Name:VINNO 8, VINNO 6, VINNO 5
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant VINNO Technology (Suzhou) Co., Ltd. 5F Building A, 4F Building C No. 27 XinFa Rd. Suzhou Industrial Park Suzhou,  CN 215123
ContactWei Wang
CorrespondentSherry Zhang
VINNO Technology (Suzhou) Co., Ltd. 5F Building A, 4F Building C No. 27 XinFa Rd. Suzhou Industrial Park Suzhou,  CN 215123
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
510k Review PanelRadiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-01-24
Decision Date2020-01-23

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