The following data is part of a premarket notification filed by Inomed Medizintechnik Gmbh with the FDA for C2 Nervemonitor System With Accessories.
| Device ID | K111647 |
| 510k Number | K111647 |
| Device Name: | C2 NERVEMONITOR SYSTEM WITH ACCESSORIES |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | INOMED MEDIZINTECHNIK GMBH IM HAUSGRUEN 29 Emmendingen, DE 79312 |
| Contact | Saschka Busch |
| Correspondent | Saschka Busch INOMED MEDIZINTECHNIK GMBH IM HAUSGRUEN 29 Emmendingen, DE 79312 |
| Product Code | GWF |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-13 |
| Decision Date | 2011-10-06 |
| Summary: | summary |