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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 K844966
Device Name CARDIOBEEPER PROFILE MONITOR
Applicant
SURVIVAL TECHNOLOGY, INC.
8101 GLENBROOK RD.
BETHESDA,  MD  20814
Applicant Contact GARY W LEYLAND
Correspondent
SURVIVAL TECHNOLOGY, INC.
8101 GLENBROOK RD.
BETHESDA,  MD  20814
Correspondent Contact GARY W LEYLAND
Regulation Number870.2920
Classification Product Code
DXH  
Date Received12/24/1984
Decision Date 02/08/1985
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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