FDA 510(k) Application Details - K231984

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K231984
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	Shenzhen Hingmed Medical Instrument Co., Ltd. 4th Floor, Zhonghangfeixiang Building, NO. 371, Guangshen Road, Baoan District Shenzhen 518102 CN Other 510(k) Applications for this Company
Contact	Huang YongBan 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	07/05/2023
Decision Date	03/26/2024
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