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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K151258
Device Name Arm automatic blood pressure monitor
Applicant
Shenzhen Pump Medical System Co., Ltd.
2/F W., M-7 Sinosteel Bldg., Maqueling Estate
Hi-Tech Industrial Park
Nanshan District, Shenzhen,  CN 518057
Applicant Contact Xie Qiongyu
Correspondent
Shenzhen Pump Medical System Co., Ltd.
2/F W., M-7 Sinosteel Bldg., Maqueling Estate
Hi-Tech Industrial Park
Nanshan District, Shenzhen,  CN 518057
Correspondent Contact Migo Yang
Regulation Number870.1130
Classification Product Code
DXN  
Date Received05/12/2015
Decision Date 02/18/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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