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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 K884152
Device Name CENTURY COLOR TRACE
Applicant
Biomedical Systems, Inc.
77 W. Port Plz.
St. Louis,  MO  63146
Applicant Contact TIMOTHY R BARRETT
Correspondent
Biomedical Systems, Inc.
77 W. Port Plz.
St. Louis,  MO  63146
Correspondent Contact TIMOTHY R BARRETT
Regulation Number870.1025
Classification Product Code
DSI  
Date Received10/03/1988
Decision Date 12/15/1988
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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