Medical Device Manufacturer · US , Eden Prairie , MN

Neuroone Medical Technologies Corp. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2021
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Neuroone Medical Technologies Corp. Neurology ✕
4 devices
1-4 of 4
Cleared Aug 15, 2025
OneRF Trigeminal Nerve Radiofrequency Probes
K251243 · GXI
Neurology · 115d
Cleared Dec 06, 2023
OneRF Ablation System
K231675 · GXD
Neurology · 181d
Cleared Oct 20, 2022
Evo® sEEG System
K222404 · GZL
Neurology · 72d
Cleared Sep 01, 2021
Evo sEEG System
K211367 · GZL
Neurology · 120d
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