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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 K132627
Device Name AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
Applicant
Honsun (Nantong) Co., Ltd.
#8, Tongxing Rd., Nantong Economic &
Technological Development Area
Nantong, Jiangsu,  CN 226009
Applicant Contact SELINA QIAN
Correspondent
Honsun (Nantong) Co., Ltd.
#8, Tongxing Rd., Nantong Economic &
Technological Development Area
Nantong, Jiangsu,  CN 226009
Correspondent Contact SELINA QIAN
Regulation Number870.1130
Classification Product Code
DXN  
Date Received08/22/2013
Decision Date 10/23/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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