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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 K092683
Device Name DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL LD 1143
Applicant
Shanghai Little Doctor Co. Limited
# 8 Tongxing Rd.
Nantong, Jiangsu,  CN 26007
Applicant Contact JANUSUN WANG
Correspondent
Shanghai Little Doctor Co. Limited
# 8 Tongxing Rd.
Nantong, Jiangsu,  CN 26007
Correspondent Contact JANUSUN WANG
Regulation Number870.1130
Classification Product Code
DXN  
Date Received09/01/2009
Decision Date 09/25/2009
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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