FDA 510(k) Application Details - K190683

Device Classification Name	Device, Counter-Pulsating, External   More FDA Info for this Device
510(K) Number	K190683
Device Name	Device, Counter-Pulsating, External
Applicant	Vamed Medical Instrument Co., Ltd 1 of 8 Floor, 2# Building, No. 60, Lang bao West Road, Chancheng District Foshan 528000 CN Other 510(k) Applications for this Company
Contact	Ji Mia Other 510(k) Applications for this Contact
Regulation Number	870.5225   More FDA Info for this Regulation Number
Classification Product Code	DRN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/18/2019
Decision Date	09/10/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review