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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 K170866
Device Name Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579
Applicant
Honsun (Nantong) Co., Ltd.
#8,Tongxing Rd., Economic&Technology Development Zone
Nantong
Nantong,  CN 226009
Applicant Contact Selina Qian
Correspondent
Honsun (Nantong) Co., Ltd.
#8,Tongxing Rd., Economic&Technology Development Zone
Nantong
Nantong,  CN 226009
Correspondent Contact Selina Qian
Regulation Number870.1130
Classification Product Code
DXN  
Date Received03/23/2017
Decision Date 02/21/2018
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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