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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 K963811
Device Name CARD GUARD MODEL CG-6106 PERSONAL ELECTROCARDIOGRAM (ECG) TRANSMITTER DEVICE
Applicant
Card Guard Scientific Survival , Ltd.
6156 E. Greenway Ln.
Scottsdale,  AZ  85254
Applicant Contact BOAZ VINOGRADOV
Correspondent
Card Guard Scientific Survival , Ltd.
6156 E. Greenway Ln.
Scottsdale,  AZ  85254
Correspondent Contact BOAZ VINOGRADOV
Regulation Number870.2920
Classification Product Code
DXH  
Date Received09/23/1996
Decision Date 12/04/1996
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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