Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

NeuTrace EP Mapping System v.2.1

K-Number: K233160 · 2023-11-25

ApplicantAnumana, Inc.
Decision Date2023-11-25
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NeuTrace EP Mapping System v.2.1 is a medical device manufactured by Anumana, Inc.. It received FDA 510(k) clearance on 2023-11-25 under approval number K233160. 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 NeuTrace EP Mapping System v.2.1?

NeuTrace EP Mapping System v.2.1 is a medical device that received FDA 510(k) clearance on 2023-11-25. It is manufactured by Anumana, Inc.. The 510(k) number is K233160.

When was NeuTrace EP Mapping System v.2.1 approved by the FDA?

NeuTrace EP Mapping System v.2.1 received FDA 510(k) clearance on 2023-11-25, under approval number K233160.

What company makes NeuTrace EP Mapping System v.2.1?

NeuTrace EP Mapping System v.2.1 is manufactured by Anumana, Inc..

What is the FDA product code for NeuTrace EP Mapping System v.2.1?

The FDA product code for NeuTrace EP Mapping System v.2.1 is DQK.

Related Clinical Trials

NCT07137455 EDEN Intracardiac Electrogram Recording and Classifying System ENROLLING_BY_INVITATION NCT03280862 DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS COMPLETED NCT06510556 Feasibility Study of the FARAFLEX Mapping and PFA System RECRUITING NCT03053141 RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY) RECRUITING NCT07221565 Electromagnetic Immunotherapy Mapping and Cytokine Forecasting Study (QSIT) ENROLLING_BY_INVITATION NCT05225935 Computed Tomography-Guided Catheter Ablation for Ventricular Tachycardia COMPLETED

Other Devices by Anumana, Inc.

K232699Low Ejection Fraction AI-ECG Algorithm K250652ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) K253801ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) K252360ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)

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.

↑