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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 K123600
Device Name DIGITAL BLOOD PRESSURE MONITOR
Applicant
Little Doctor Electronic (Nantong)Co.,Ltd
# 8, Tongxing Rd.
Nantong Economic & Technology Development Zone
Nantong, Jiangsu,  CN 226009
Applicant Contact SELINA QIAN
Correspondent
Little Doctor Electronic (Nantong)Co.,Ltd
# 8, Tongxing Rd.
Nantong Economic & Technology Development Zone
Nantong, Jiangsu,  CN 226009
Correspondent Contact SELINA QIAN
Regulation Number870.1130
Classification Product Code
DXN  
Date Received11/21/2012
Decision Date 05/03/2013
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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