FDA 510(k) Application Details - K213503

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K213503
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	Shenzhen AOJ Medical Technology Co., Ltd. Room 301&4F, Blk A, Building A, Jingfa IM Park, Xiaweiyuan, Gushu Community, Xixiang, Baoan Shenzhen 518126 CN Other 510(k) Applications for this Company
Contact	Queena Chen 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	11/01/2021
Decision Date	02/18/2022
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