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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K123217
Device Name CARDEASCREEN
Applicant
Cardea Associates, Inc.
137220 220th Place NE
Woodinville,  WA  98077
Applicant Contact DAVID M HADLEY
Correspondent
Underwriters Laboratories, Inc.
12 Laboratory Dr.
Research Triangel Park,  NC  27709
Correspondent Contact JEFF D RONGERO
Regulation Number870.2340
Classification Product Code
DPS  
Date Received10/15/2012
Decision Date 02/05/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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