FDA 510(k) Application Details - K212171

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K212171
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	Dongguan Kangweile Electronic Technology Co., Ltd. 4th Floor, Building D, Yizhong Science Park, 83 Jisha 2nd Road, Shuikou Village, Dalang Town Dongguan 523770 CN Other 510(k) Applications for this Company
Contact	Zhixin Gao Other 510(k) Applications for this Contact
Regulation Number	870.1130   More FDA Info for this Regulation Number
Classification Product Code	DXN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/12/2021
Decision Date	11/01/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review