510(k) K233621 ยท OBP Transcranial Magnetic Stimulator
NeuroStar Advanced Therapy System (Version 3.8)
| Applicant | Neuronetics, Malvern PA, US |
| Decision | Substantially Equivalent, Dec 13, 2023 |
| Received | Nov 13, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K233621
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 9, 2026 | Neuronetics, Inc. NeuroStar Advanced Therapy System. Contains the NeuroStar HP Coil Assembly Part Number 81-01000-200. Affects the below NeuroStar Advanced Therapy Systems:
1. NeuroStar 2.0 US; Part Number: 81-01315-0 Open, Classified |
OBP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.