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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 K922783
Device Name ES1700 ECG MODULATOR
Applicant
Epic Systems, Inc.
P.O. Box 908
Darby,  MT  59829
Applicant Contact JAY M ESTUS
Correspondent
Epic Systems, Inc.
P.O. Box 908
Darby,  MT  59829
Correspondent Contact JAY M ESTUS
Regulation Number870.2920
Classification Product Code
DXH  
Date Received06/09/1992
Decision Date 01/07/1993
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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