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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 K211546
Device Name Vektor Computational ECG Mapping System (vMap)
Applicant
Vektor Medical, Inc.
7875 Sitio Abeto
Carlsbad,  CA  92009
Applicant Contact Mike Monko
Correspondent
Experien Group, LLC
224 Airport Parkway, Suite 250
San Jose,  CA  95110
Correspondent Contact Michael J Billig
Regulation Number870.1425
Classification Product Code
DQK  
Date Received05/19/2021
Decision Date 11/09/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT04559061
Reviewed by Third Party No
Combination Product No
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