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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 K090496
Device Name QWIKLEAD REUSABLE ELECTROCARDIOGRAPH ELECTRODE PATCH
Applicant
Cardiac Lead Technologies, Inc.
575 7th St., NW
Washington,  DC  20004
Applicant Contact CLAUDIA LEWIS-ENG
Correspondent
Cardiac Lead Technologies, Inc.
575 7th St., NW
Washington,  DC  20004
Correspondent Contact CLAUDIA LEWIS-ENG
Regulation Number870.2360
Classification Product Code
DRX  
Date Received02/25/2009
Decision Date 09/01/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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