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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
Device Name TL-200 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM
Applicant
TENSYS MEDICAL SYSTEMS, INC
5825 OBERLIN DRIVE
SUITE 100
SAN DIEGO,  CA  92121
Applicant Contact Jamie Sulley
Correspondent
TENSYS MEDICAL SYSTEMS, INC
5825 OBERLIN DRIVE
SUITE 100
SAN DIEGO,  CA  92121
Correspondent Contact Jamie Sulley
Regulation Number870.1130
Classification Product Code
DXN  
Date Received04/16/2012
Decision Date 05/15/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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