FDA 510(k) Application Details - K181104

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K181104
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	Shenzhen Combei Technology CO., LTD 11-5B No.105, Huanguan South Road, Dahe Community, Guanlan Guanlan, Shenzhen 518110 CN Other 510(k) Applications for this Company
Contact	Kevin Fong 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	04/26/2018
Decision Date	08/29/2018
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