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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 K890461
Device Name CARDIOBEEPER IV
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 Received01/30/1989
Decision Date 02/23/1989
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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