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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 K130232
Device Name ELECTRONIC BLOOD PRESSURE MONITOR FOR UPPER ARM
Applicant
Jinxinbao Electronic Co.,Ltd
Rm. 404, Bldg. 7, Jinhuichang Homeland
Liuhongqiao Rd.
Wenzhou, Zhejiang,  CN 325000
Applicant Contact HELEN NAN
Correspondent
Jinxinbao Electronic Co.,Ltd
Rm. 404, Bldg. 7, Jinhuichang Homeland
Liuhongqiao Rd.
Wenzhou, Zhejiang,  CN 325000
Correspondent Contact HELEN NAN
Regulation Number870.1130
Classification Product Code
DXN  
Date Received01/29/2013
Decision Date 09/17/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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