The following data is part of a premarket notification filed by Eb Neuro, S.p.a. with the FDA for Nemus 2 System.
| Device ID | K133517 |
| 510k Number | K133517 |
| Device Name: | NEMUS 2 SYSTEM |
| Classification | Amplifier, Physiological Signal |
| Applicant | EB NEURO, S.P.A. 9001 WESLEYAN RD, STE 200 Indianapolis, IN 46268 |
| Contact | Allison Scott, Rac |
| Correspondent | Allison Scott, Rac EB NEURO, S.P.A. 9001 WESLEYAN RD, STE 200 Indianapolis, IN 46268 |
| Product Code | GWL |
| Subsequent Product Code | GWE |
| Subsequent Product Code | GWF |
| Subsequent Product Code | GWJ |
| CFR Regulation Number | 882.1835 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-15 |
| Decision Date | 2014-02-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08056446900376 | K133517 | 000 |
| 08056446900369 | K133517 | 000 |
| 08056446900352 | K133517 | 000 |
| 08056446900345 | K133517 | 000 |
| 08056446900338 | K133517 | 000 |