The following data is part of a premarket notification filed by Neuronetics, Inc. with the FDA for Neurostar, Neurostar Tms Therapy System, Neurostar Advanced Therapy System, Neurostar Advanced Therapy System For Mental Health.
| Device ID | K222230 |
| 510k Number | K222230 |
| Device Name: | NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System For Mental Health |
| Classification | Transcranial Magnetic Stimulator |
| Applicant | Neuronetics, Inc. 3222 Phoenixville Pike Malvern, PA 19355 |
| Contact | Amanda Pentecost |
| Correspondent | Amanda Pentecost Neuronetics, Inc. 3222 Phoenixville Pike Malvern, PA 19355 |
| Product Code | OBP |
| CFR Regulation Number | 882.5805 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-25 |
| Decision Date | 2022-08-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850005944539 | K222230 | 000 |