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FDA 510(k)

Vektor Computational ECG Mapping System (vMap)

K-Number: K211546 · 2021-11-09

ApplicantVektor Medical, Inc.
Decision Date2021-11-09
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Vektor Computational ECG Mapping System (vMap) is a medical device manufactured by Vektor Medical, Inc.. It received FDA 510(k) clearance on 2021-11-09 under approval number K211546. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vektor Computational ECG Mapping System (vMap)?

Vektor Computational ECG Mapping System (vMap) is a medical device that received FDA 510(k) clearance on 2021-11-09. It is manufactured by Vektor Medical, Inc.. The 510(k) number is K211546.

When was Vektor Computational ECG Mapping System (vMap) approved by the FDA?

Vektor Computational ECG Mapping System (vMap) received FDA 510(k) clearance on 2021-11-09, under approval number K211546.

What company makes Vektor Computational ECG Mapping System (vMap)?

Vektor Computational ECG Mapping System (vMap) is manufactured by Vektor Medical, Inc..

What is the FDA product code for Vektor Computational ECG Mapping System (vMap)?

The FDA product code for Vektor Computational ECG Mapping System (vMap) is DQK.

Related Clinical Trials

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Other Devices by Vektor Medical, Inc.

K252429Vektor Computational ECG Mapping System (vMap®)

Related Devices (Code: DQK)

K160218AutoMark ModuleSt Jude Medical K160210EnSite Precision Cardiac Mapping System v2.0St Jude Medical K162643MediGuide Technology SystemSt Jude Medical K162440CardioInsight Cardiac Mapping SystemCardioinsight Technologies, Inc. K160187Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0St Jude Medical K160186EnSite Velocity Surface Electrode KitSt Jude Medical

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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