510(k) K252429

Vektor Computational ECG Mapping System (vMap®) by Vektor Medical, Inc. — Product Code DQK

K252429 is an FDA 510(k) premarket notification submitted by Vektor Medical, Inc. for the device "Vektor Computational ECG Mapping System (vMap®)". The FDA issued a decision of Substantially Equivalent on Dec 4, 2025. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. Vektor Medical, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Dec 4, 2025
Date Received
Aug 1, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Programmable
Device Class
Class II
Regulation Number
870.1425
Review Panel
CV
Submission Type