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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 K925535
Device Name CARDIOBEEPER(R) CB-IIA
Applicant
Survival Technology, Inc.
2275 Research Blvd.
Rockville,  MD  20850
Applicant Contact GARY W LEYLAND
Correspondent
Survival Technology, Inc.
2275 Research Blvd.
Rockville,  MD  20850
Correspondent Contact GARY W LEYLAND
Regulation Number870.2920
Classification Product Code
DXH  
Date Received11/02/1992
Decision Date 01/28/1993
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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