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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 K942704
Device Name CARD GUARD, MODEL CG-7000D ECG RECORDER/TRANSMITTER
Applicant
Card Guard Scientific Survival , Ltd.
19636 Club House Rd., #120
Gaithersburg,  MD  20879
Applicant Contact DANIEL GERSHONI
Correspondent
Card Guard Scientific Survival , Ltd.
19636 Club House Rd., #120
Gaithersburg,  MD  20879
Correspondent Contact DANIEL GERSHONI
Regulation Number870.2920
Classification Product Code
DXH  
Date Received06/08/1994
Decision Date 12/05/1994
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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