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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 K182571
Device Name CardioFlux with Faraday Analytical Cloud
Applicant
Genetesis, Inc.
5412 Courseview Dr., Suite 150
Mason,  OH  45040
Applicant Contact Robert Sokolowski
Correspondent
Genetesis, Inc.
5412 Courseview Dr., Suite 150
Mason,  OH  45040
Correspondent Contact Robert Sokolowski
Regulation Number870.2340
Classification Product Code
DPS  
Date Received09/18/2018
Decision Date 03/15/2019
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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