FDA 510(k) Application Details - K231478

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K231478
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	Wenzhou Yosun Medical Technology Co.,Ltd No.17 ,Shahong Road,Lingmen Beibaixiang Town Yueqing Wenzhou 325603 CN Other 510(k) Applications for this Company
Contact	Xiao Yuan Lan 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	05/22/2023
Decision Date	12/15/2023
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