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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K863535
Device Name LIFE-TRACE 18 SINGLE-TRACE CARDIAC MONITOR/RECORD.
Applicant
Computerized Medical Systems, Inc.
3555 Woodhead Dr.
Northbrook,  IL  60062
Applicant Contact GARY W HENDRICKSON
Correspondent
Computerized Medical Systems, Inc.
3555 Woodhead Dr.
Northbrook,  IL  60062
Correspondent Contact GARY W HENDRICKSON
Regulation Number870.2340
Classification Product Code
DPS  
Date Received09/11/1986
Decision Date 01/06/1987
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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