The following data is part of a premarket notification filed by Inomed Medizintechnik Gmbh with the FDA for C2 Nervemonitor System.
| Device ID | K152505 |
| 510k Number | K152505 |
| Device Name: | C2 NerveMonitor System |
| Classification | Stimulator, Nerve |
| Applicant | INOMED MEDIZINTECHNIK GMBH IM HAUSGRUEN 29 Emmendingen Baden- Wuerttemberg, DE D- 79312 |
| Contact | Saschka Busch |
| Correspondent | Saschka Busch INOMED MEDIZINTECHNIK GMBH IM HAUSGRUEN 29 Emmendingen Baden- Wuerttemberg, DE D- 79312 |
| Product Code | ETN |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-02 |
| Decision Date | 2016-02-01 |
| Summary: | summary |