External Counterpulsation System, Soulaire

Device, Counter-pulsating, External

Vamed Medical Instrument Co., Ltd.

The following data is part of a premarket notification filed by Vamed Medical Instrument Co., Ltd. with the FDA for External Counterpulsation System, Soulaire.

Pre-market Notification Details

Device IDK202108
510k NumberK202108
Device Name:External Counterpulsation System, Soulaire
ClassificationDevice, Counter-pulsating, External
Applicant Vamed Medical Instrument Co., Ltd. 1 Of 8 Floor, 2# Building, No. 60, Langbao West Road, Chancheng District Foshan,  CN 413200
ContactJi Ma
CorrespondentJet Li
Guangzhou Keda Biological Tech Co., Ltd. 6F, No. 1 TianTai Road, Science City, LuoGang District Guangzhou,  CN 510060
Product CodeDRN  
CFR Regulation Number870.5225 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-30
Decision Date2020-08-28

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