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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
510(k) Number K033133
Device Name TELECARE D.R. SERVER SOFTWARE SYSTEM
Applicant
Healthcare Vision, Inc.
2601 Scott Ave.
Suite 600
Fort Worth,  TX  76103
Applicant Contact CRAIG WALKER
Correspondent
Healthcare Vision, Inc.
2601 Scott Ave.
Suite 600
Fort Worth,  TX  76103
Correspondent Contact CRAIG WALKER
Regulation Number870.2300
Classification Product Code
MWI  
Date Received09/30/2003
Decision Date 04/13/2004
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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