NEUROONE MEDICAL TECHNOLOGIES CORP.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30164386863016438686NEUROONE MEDICAL TECHNOLOGIES CORP.1N2026-01-017599 Anagram Drive Eden Prairie MN US 55344

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2375581644427407K251243OneRF Trigeminal Nerve Radiofrequency ProbesGXI2025-08-15
2375581229259864K231675OneRF Ablation SystemGXD2023-12-06
2375581494536947K222404Evo® sEEG SystemGZL2022-10-20
2375581918802896K211367Evo sEEG SystemGZL2021-09-01
2375581777368696K192764NeuroOne Cortical ElectrodeGYC2019-11-26

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GZL22022-10-20
GXI12025-08-15
GXD12023-12-06
GYC12019-11-26

PMN#