FDA 510(k) Application Details - K151258

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K151258
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, GUANGDONG 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	05/12/2015
Decision Date	02/18/2016
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