FDA 510(k) Application Details - K250116

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K250116
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	Shenzhen AOJ Medical Technology Co., Ltd Rm 301&4F,Block A, Bldg A,ingfa Intelligent Manufacturing Pk Xiaweiyuan, Gushu Community, Xixiang Street, Bao'an District Shenzhen 518126 CN Other 510(k) Applications for this Company
Contact	Jack Wang 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	01/16/2025
Decision Date	04/24/2025
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