FDA 510(k) Application Details - K210671

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K210671
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	Weony (Shenzhen) Technology Co., Ltd. 3rd Floor B, Building 19, HeYi BeiFangYongFa Science & Technology Park, HeYi Community, ShaJing Street, Shenzhen 518104 CN Other 510(k) Applications for this Company
Contact	Autumn Liu 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	03/05/2021
Decision Date	08/13/2021
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