510(k) K183376 ยท OBP Transcranial Magnetic Stimulator
HORIZON TMS Therapy System with Navigation
| Applicant | Magstim Company, Ltd., Whitland, GB |
| Decision | Substantially Equivalent, Apr 3, 2019 |
| Received | Dec 6, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183376
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 23, 2020 | The Magstim Company Limited Horizon PSU Stim Interconnecting Cable - Product Usage: Horizon is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from p Terminated |
OBP | None listed |
| Mar 23, 2020 | The Magstim Company Limited Rapid2 PSU Stim Interconnecting Cable - Product Usage: indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antid Terminated |
OBP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.