The following data is part of a premarket notification filed by Neurosoft Ltd with the FDA for Neuro-iom System With Neuro-iom.net Software.
| Device ID | K190703 |
| 510k Number | K190703 |
| Device Name: | Neuro-IOM System With Neuro-IOM.NET Software |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | Neurosoft Ltd 5, Voronin Str. Ivanovo, RU 153032 |
| Contact | Eugene Polezhaev |
| Correspondent | Barry V Ashar Makromed, Inc. 88 Stiles Road Salem, NH 03079 |
| Product Code | GWF |
| Subsequent Product Code | GWE |
| Subsequent Product Code | GWJ |
| Subsequent Product Code | OLT |
| Subsequent Product Code | PDQ |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-18 |
| Decision Date | 2021-05-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04650075330371 | K190703 | 000 |