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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 K091414
Device Name VTRUST BLOOD PRESSURE MONITOR, MODEL VTRUST 701DH
Applicant
Biocare Corp.
4f, No 12, Ln. 5, Sec, 2
Nanshan Rd., Lujhu Township
Taoyuan,  TW 33852
Applicant Contact JUDY WEI
Correspondent
Biocare Corp.
4f, No 12, Ln. 5, Sec, 2
Nanshan Rd., Lujhu Township
Taoyuan,  TW 33852
Correspondent Contact JUDY WEI
Regulation Number870.1130
Classification Product Code
DXN  
Date Received05/13/2009
Decision Date 10/21/2009
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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