FDA 510(k) Application Details - K241613

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K241613
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	Shenzhen HBcare Technology Co.,Ltd A208, Block A and B, No.1 ChuangJin, District 28, Dalang community, Xin'an street, Baoan Shenzhen 516000 CN Other 510(k) Applications for this Company
Contact	XuYu Lee 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	06/05/2024
Decision Date	10/16/2024
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