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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Electrocardiograph, Telephone
510(k) Number K954163
Device Name RETROSPECTIVE II-ELITE ECG MEMORY LOOP RECORDER
Applicant
Cardiac Evaluation Center, Inc.
2063 S. 116th St.
P.O. Box 27327
Milwaukee,  WI  53227
Applicant Contact JIM MCGUIRE
Correspondent
Cardiac Evaluation Center, Inc.
2063 S. 116th St.
P.O. Box 27327
Milwaukee,  WI  53227
Correspondent Contact JIM MCGUIRE
Regulation Number870.2920
Classification Product Code
DXH  
Date Received09/05/1995
Decision Date 07/11/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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