The following data is part of a premarket notification filed by Eb Neuro, S.p.a. with the FDA for Nemus System; Nemus Pc Peripheral.
| Device ID | K073415 |
| 510k Number | K073415 |
| Device Name: | NEMUS SYSTEM; NEMUS PC PERIPHERAL |
| Classification | Electromyograph, Diagnostic |
| Applicant | EB NEURO, S.P.A. 11460 N. MERIDIAN ST. SUITE 150 Carmel, IN 46032 |
| Contact | Allison Scott |
| Correspondent | Allison Scott EB NEURO, S.P.A. 11460 N. MERIDIAN ST. SUITE 150 Carmel, IN 46032 |
| Product Code | IKN |
| Subsequent Product Code | GWF |
| Subsequent Product Code | GWJ |
| Subsequent Product Code | JXE |
| CFR Regulation Number | 890.1375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-04 |
| Decision Date | 2008-05-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08056446900284 | K073415 | 000 |
| 08056446900215 | K073415 | 000 |
| 08056446900222 | K073415 | 000 |
| 08056446900239 | K073415 | 000 |
| 08056446900246 | K073415 | 000 |
| 08056446900260 | K073415 | 000 |
| 08056446900277 | K073415 | 000 |
| 08056446900659 | K073415 | 000 |
| 08056446900666 | K073415 | 000 |
| 08056446900253 | K073415 | 000 |
| 08056446900208 | K073415 | 000 |