FDA 510(k) Application Details - K242528

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K242528
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	Shenzhen Ruiankang Technology Co., Ltd. Floor1 and 2, No.8, Zhugushi Chunyang Industrial Park Wulian Community, Longgang Street, Longgang District Shenzhen 518117 CN Other 510(k) Applications for this Company
Contact	Xinhua Zhao 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	08/26/2024
Decision Date	01/10/2025
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