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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 K130325
Device Name ARM AUTOMATIC BLOOD PRESSURE MONITOR
Applicant
Shenzhen Pump Medical System Co., Ltd.
Keji Nan # 12 Rd., Hi-Tech Park
Shenzhen, Guangdong,  CN 518057
Applicant Contact IVY CHEN
Correspondent
Shenzhen Pump Medical System Co., Ltd.
Keji Nan # 12 Rd., Hi-Tech Park
Shenzhen, Guangdong,  CN 518057
Correspondent Contact IVY CHEN
Regulation Number870.1130
Classification Product Code
DXN  
Date Received02/08/2013
Decision Date 12/24/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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