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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 K123446
Device Name TL-300 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM
Applicant
United States Gtm Medical Devices, Inc.
5850 Oberlin Dr. #240
San Diego,  CA  92121
Applicant Contact Kenneth K Kleinhenz
Correspondent
United States Gtm Medical Devices, Inc.
5850 Oberlin Dr. #240
San Diego,  CA  92121
Correspondent Contact Kenneth K. Kleinhenz
Regulation Number870.1130
Classification Product Code
DXN  
Date Received11/08/2012
Decision Date 12/07/2012
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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