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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Signal Isolation
510(k) Number K832828
Device Name CENTURION CARDIAC DETECTOR
Applicant
Clinical Data Instruments, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Clinical Data Instruments, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.2600
Classification Product Code
DRJ  
Date Received08/19/1983
Decision Date 05/09/1984
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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