FDA 510(k) Application Details - K251102

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K251102
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	Cemho Medical Technology (Guangdong) Co., Ltd. Cemho Medical Industrial Park, West of Xinghe Line, Dongguan Shijie (Xingning) Industrial Transfer Industrial Pk Meizhou City 514500 CN Other 510(k) Applications for this Company
Contact	Gang Hong 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	04/11/2025
Decision Date	07/16/2025
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