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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 K081852
Device Name TRULY AUTOMATIC BLOOD PRESSURE MONITOR, MODEL DB11
Applicant
Truly Instrument Limited
Truly Industrial Area
Shanwei City, Guangdong,  CN 516600
Applicant Contact YANG JIANHAO
Correspondent
Truly Instrument Limited
Truly Industrial Area
Shanwei City, Guangdong,  CN 516600
Correspondent Contact YANG JIANHAO
Regulation Number870.1130
Classification Product Code
DXN  
Date Received06/30/2008
Decision Date 12/12/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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