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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 K926515
Device Name CARD GUARD MODEL CG-8000
Applicant
Card Guard Scientific Survival , Ltd.
230 N. Washington St.
Suite 400
Rockville,  MD  20850
Applicant Contact DANIEL GERSHONI
Correspondent
Card Guard Scientific Survival , Ltd.
230 N. Washington St.
Suite 400
Rockville,  MD  20850
Correspondent Contact DANIEL GERSHONI
Regulation Number870.2920
Classification Product Code
DXH  
Date Received12/30/1992
Decision Date 03/30/1994
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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