OneRF Ablation System
Neuroone Medical Technologies Corp.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3016438686 | 3016438686 | NEUROONE MEDICAL TECHNOLOGIES CORP. | 1 | N | 2026-01-01 | 7599 Anagram Drive Eden Prairie MN US 55344 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00856895008139 | One RF Ablation System - 26.5mm x 8 Contact Trigeminal RF Probe | 952-426-1383 | customerservice@n1mtc.com |
| 00856895008146 | One RF Ablation System - 16mm x 5 Contact Trigeminal RF Probe | 952-426-1383 | customerservice@n1mtc.com |
| 00856895008153 | One RF Ablation System - Trigeminal Nerve Temperature Accessory / RF Connector Box | 952-426-1383 | CustomerService@N1MTC.com |
| 00856895008634 | OneRF Ablation System - 61.5mm x 16 Contact sEEG - RF Probe | 952-426-1383 | CustomerService@N1MTC.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 237558 | 1644427407 | K251243 | OneRF Trigeminal Nerve Radiofrequency Probes | GXI | 2025-08-15 |
| 237558 | 1229259864 | K231675 | OneRF Ablation System | GXD | 2023-12-06 |
| 237558 | 1494536947 | K222404 | Evo® sEEG System | GZL | 2022-10-20 |
| 237558 | 1918802896 | K211367 | Evo sEEG System | GZL | 2021-09-01 |
| 237558 | 1777368696 | K192764 | NeuroOne Cortical Electrode | GYC | 2019-11-26 |
Neuroone Medical Technologies Corp.
NeuroOne Medical Technologies Corp.
NeuroOne Medical Technologies Corp.
NeuroOne, Inc.
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