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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 K834034
Device Name MODEM ACCESSORY FOR EPI CARDIA SYS
Applicant
MEDICOMP, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
MEDICOMP, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number870.2920
Classification Product Code
DXH  
Date Received11/23/1983
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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