510(k) K083538 ยท OBP Transcranial Magnetic Stimulator
NEUROSTAR TMS THERAPY SYSTEM, MODEL 1.1
| Applicant | Neuronetics, Malvern PA, US |
| Decision | Substantially Equivalent, Dec 16, 2008 |
| Received | Nov 28, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K083538
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 27, 2009 | Neuronetics, Inc. NeuroStar TMS Therapy System/SenStar Treatment Link.
The SenStar Treatment Link is a single use, disposable component of the NeuroStar TMS system, a non-invasive treatment for depression using highly Terminated |
OBP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.