The following data is part of a premarket notification filed by Neuronetics, Inc with the FDA for Neurostar Tms Therapy System, Neurostar Advanced Therapy System, Neurostar, Neurostar Advanced Therapy For Mental Health.
| Device ID | K220127 |
| 510k Number | K220127 |
| Device Name: | NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy For Mental Health |
| Classification | Transcranial Magnetic Stimulator |
| Applicant | Neuronetics, Inc 3222 Phoenixville Pike Malvern, PA 19355 |
| Contact | Cory Anderson |
| Correspondent | Robin Fatzinger Neuronetics, Inc 3222 Phoenixville Pike Malvern, PA 19355 |
| Product Code | OBP |
| CFR Regulation Number | 882.5805 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-18 |
| Decision Date | 2022-07-15 |