The following data is part of a premarket notification filed by Inomed Medizintechnik Gmbh with the FDA for Isis Headboxes, Isis Neurostimulator, Isis Xpert Plus, Isis Xpert, Isis Xpress.
| Device ID | K212166 |
| 510k Number | K212166 |
| Device Name: | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | inomed Medizintechnik GmbH Im Hausgruen 29 Emmendingen, DE 79312 |
| Contact | Tomasz Moszkowski |
| Correspondent | Alexander Maier inomed Medizintechnik GmbH Im Hausgruen 29 Emmendingen, DE 79312 |
| Product Code | GWF |
| Subsequent Product Code | ETN |
| Subsequent Product Code | GWE |
| Subsequent Product Code | GWJ |
| Subsequent Product Code | GWQ |
| Subsequent Product Code | IKN |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-12 |
| Decision Date | 2022-01-07 |