FDA 510(k) Application Details - K222160

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K222160
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	Globalcare Medical Technology Co., Ltd. No. 7 Factory, European Industrial Park, No. 39 Mid Industrial Road, Xiaolan Town Zhongshan City 528415 CN Other 510(k) Applications for this Company
Contact	Chiara Cavagnolo 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	07/20/2022
Decision Date	11/22/2022
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