FDA 510(k) Application Details - K161712

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K161712
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. 2/F WEST, M-7 SINOSTEEL BUILDING, MAQUELING ESTATE HI-TECH INDUSTRIAL PARK NANSHAN DISTRICT, SHENZHEN 518057 CN Other 510(k) Applications for this Company
Contact	XIE QIONGYU 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	06/21/2016
Decision Date	04/05/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review