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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 K073094
Device Name VITALLINK3 MOBILE VITAL SIGNS SYSTEM
Applicant
Telemedic Systems, Ltd.
10 Billetfield
Taunton, Somerset,  GB TA1 3NN
Applicant Contact GERALD L BUSS
Correspondent
Telemedic Systems, Ltd.
10 Billetfield
Taunton, Somerset,  GB TA1 3NN
Correspondent Contact GERALD L BUSS
Regulation Number870.2300
Classification Product Code
MWI  
Date Received11/01/2007
Decision Date 01/04/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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