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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Network And Communication, Physiological Monitors
510(k) Number K973640
Device Name TS2000 MEDICAL DEVICE MONITOR
Applicant
Trincore Systems, Inc.
7409 Butternut Ct.
Fort Worth,  TX  76137
Applicant Contact VINCENT OCCHIPINTI
Correspondent
Trincore Systems, Inc.
7409 Butternut Ct.
Fort Worth,  TX  76137
Correspondent Contact VINCENT OCCHIPINTI
Regulation Number870.2300
Classification Product Code
MSX  
Date Received09/24/1997
Decision Date 03/12/1998
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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