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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 K143436
Device Name InvisionECG System
InvisionHeart Inc.
121 17th Avenue South
nashville,  TN  37203
Applicant Contact michael wurst
Speed to Market, Inc.
PO Box 3018
nederland,  CO  80466
Correspondent Contact thomas kroenke
Regulation Number870.2340
Classification Product Code
Date Received12/01/2014
Decision Date 05/21/2015
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No