Clearance Summary
Neuron-Spectrum-AM with Neuron-Spectrum.NET Software received FDA 510(k) clearance under submission number K220254, sponsored by Neurosoft , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2022-11-30.
- Submission: K220254
- Applicant / Sponsor: Neurosoft , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 2022-11-30
Classification & Regulation
This clearance is catalogued under FDA product code OLT and 21 CFR 882.1400, within the Neurology review panel as a Class II device.