510(k) K212166 ยท GWF Stimulator, Electrical, Evoked Response
ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress
| Applicant | Inomed Medizintechnik GmbH, Emmendingen, DE |
| Decision | Substantially Equivalent, Jan 7, 2022 |
| Received | Jul 12, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212166
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.