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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 K070825
Device Name LD8 DIGITAL WRIST BLOOD PRESSURE MONITOR
Applicant
Little Doctor (Shanghai) Electronic Manufacturing
Rm. C,Floor 22, Zhiyuan Bldg
# 768 Xietu Rd.
Shanghai,  CN 20023
Applicant Contact David Zhang
Correspondent
Little Doctor (Shanghai) Electronic Manufacturing
Rm. C,Floor 22, Zhiyuan Bldg
# 768 Xietu Rd.
Shanghai,  CN 20023
Correspondent Contact David Zhang
Regulation Number870.1130
Classification Product Code
DXN  
Date Received03/26/2007
Decision Date 05/25/2007
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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