FDA 510(k) Application Details - K231250

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K231250
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	Guangdong Genial Technology Co., Ltd. I-6-05-02 11th Road, Area B, Guangfozhao Economic Cooperation Zone, Zhagang Town, Huaiji County Zhaoqing 526437 CN Other 510(k) Applications for this Company
Contact	Yu Jun 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	05/01/2023
Decision Date	11/28/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review