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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 K121141
Model TL-200
Device Name TL-200 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM
Original Applicant
TENSYS MEDICAL SYSTEMS, INC
5825 oberlin drive
suite 100
san diego,  CA  92121
Original Contact jamie sulley
Regulation Number870.1130
Classification Product Code
DXN  
Date Received04/16/2012
Decision Date 05/15/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
statement statement
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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