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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detector And Alarm, Arrhythmia
510(k) Number K002604
Device Name CENTURION 2000 CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM
Applicant
Invivo Research, Inc.
12601 Research Pkwy.
Orlando,  FL  32826
Applicant Contact FRANCIS X CASEY
Correspondent
Invivo Research, Inc.
12601 Research Pkwy.
Orlando,  FL  32826
Correspondent Contact FRANCIS X CASEY
Regulation Number870.1025
Classification Product Code
DSI  
Date Received08/22/2000
Decision Date 02/07/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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