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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K220306
Device Name ECGenius System
Applicant
Cath Vision Aps
Titangade 11
Copenhagen N,  DK 2200
Applicant Contact Mads Matthiesen
Correspondent
Graematter, Inc.
1324 Clarkson Clayton Ctr
#332
Ballwin,  MO  63011
Correspondent Contact Sharon Bishop
Regulation Number870.1425
Classification Product Code
DQK  
Date Received02/02/2022
Decision Date 05/03/2022
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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