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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Electrocardiograph
510(k) Number K932903
Device Name EKG VEST
Applicant
Cardiotronics, Inc.
1730 Pennsylvania Ave., NW
Washington,  DC  20008
Applicant Contact JILL SWERDLOFF KLEIN
Correspondent
Cardiotronics, Inc.
1730 Pennsylvania Ave., NW
Washington,  DC  20008
Correspondent Contact JILL SWERDLOFF KLEIN
Regulation Number870.2360
Classification Product Code
DRX  
Date Received06/16/1993
Decision Date 02/24/1995
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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