The following data is part of a premarket notification filed by Neuronetics, Inc with the FDA for Neurostar Advanced Therapy For Adjunctive Treatment Of Ocd, Neurostar Advanced Therapy System, Neurostar Tms Therapy System, Neurostar Advanced Therapy For Mental Health, Neurostar.
| Device ID | K212289 |
| 510k Number | K212289 |
| Device Name: | NeuroStar Advanced Therapy For Adjunctive Treatment Of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy For Mental Health, NeuroStar |
| Classification | Transcranial Magnetic Stimulation System For Obsessive-compulsive Disorder |
| 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 | QCI |
| CFR Regulation Number | 882.5802 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-21 |
| Decision Date | 2022-05-06 |