FDA 510(k) Application Details - K232815

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K232815
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	Zhuhai Yueja Medical Device Technology Co.,Ltd. Room 201, Building 2, No.2 Liushi Road, Tangjiawan Town, High-tech Zone Zhuhai 519000 CN Other 510(k) Applications for this Company
Contact	Feng Yan 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	09/13/2023
Decision Date	12/11/2023
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