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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 K915224
Device Name CARDIOPHONICS MEMORY TRANSMITTER
Applicant
RLT MEDICAL ASSOC., INC.
18 WALLY CT.
TIMONIUM,  MD  21093
Applicant Contact RICHARD TRADER
Correspondent
RLT MEDICAL ASSOC., INC.
18 WALLY CT.
TIMONIUM,  MD  21093
Correspondent Contact RICHARD TRADER
Regulation Number870.2920
Classification Product Code
DXH  
Date Received11/20/1991
Decision Date 02/07/1992
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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