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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 K252429
Device Name Vektor Computational ECG Mapping System (vMap®)
Applicant
Vektor Medical, Inc.
9255 Towne Centre Dr.
Suite 840
San Diego,  CA  92121
Applicant Contact Mihir Naik
Correspondent
Vektor Medical, Inc.
9255 Towne Centre Dr.
Suite 840
San Diego,  CA  92121
Correspondent Contact Mihir Naik
Regulation Number870.1425
Classification Product Code
DQK  
Date Received08/01/2025
Decision Date 12/04/2025
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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