The following data is part of a premarket notification filed by Neurosoft Ltd. with the FDA for Neuron-spectrum-am With Neuron-spectrum.net Software.
| Device ID | K220254 |
| 510k Number | K220254 |
| Device Name: | Neuron-Spectrum-AM With Neuron-Spectrum.NET Software |
| Classification | Non-normalizing Quantitative Electroencephalograph Software |
| Applicant | Neurosoft Ltd. 5, Voronin Str. Ivanovo, RU 153032 |
| Contact | Michael Durdin |
| Correspondent | Vicki Chester CortiCare, Inc. 5950 La Place Court, Ste. 160 Carlsbad, CA 92008 |
| Product Code | OLT |
| Subsequent Product Code | GWQ |
| Subsequent Product Code | OLV |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-31 |
| Decision Date | 2022-11-30 |