The following data is part of a premarket notification filed by Neurosoft Ltd with the FDA for Neuron-spectrum-4/p With Neuron-spectrum.net Software.
| Device ID | K133995 |
| 510k Number | K133995 |
| Device Name: | NEURON-SPECTRUM-4/P WITH NEURON-SPECTRUM.NET SOFTWARE |
| Classification | Non-normalizing Quantitative Electroencephalograph Software |
| Applicant | NEUROSOFT LTD VIA MARZIA N. 9 Abano Terme, Padova, IT 35031 |
| Contact | Enrico Bisson |
| Correspondent | Enrico Bisson NEUROSOFT LTD VIA MARZIA N. 9 Abano Terme, Padova, IT 35031 |
| 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 | 2013-12-26 |
| Decision Date | 2015-06-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04650075330135 | K133995 | 000 |
| 04650075330128 | K133995 | 000 |
| 04650075330111 | K133995 | 000 |
| 04650075330104 | K133995 | 000 |
| 04650075330098 | K133995 | 000 |
| 04650075333211 | K133995 | 000 |