FDA 510(k) Application Details - K160019

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K160019
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	SHENZHEN URION TECHNOLOGY CO.,LTD 4TH BUILDING, HI-TECH INDUSTRIAL ZONE, HEPING COMMUNITY, FUYONG STREET, BAOAN SHENZHEN 518103 CN Other 510(k) Applications for this Company
Contact	AUTUMN LIU 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	01/05/2016
Decision Date	04/22/2016
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