The following data is part of a premarket notification filed by Neuronetics with the FDA for Neurostar Tms Therapy System, Model 1.1.
| Device ID | K083538 |
| 510k Number | K083538 |
| Device Name: | NEUROSTAR TMS THERAPY SYSTEM, MODEL 1.1 |
| Classification | Transcranial Magnetic Stimulator |
| Applicant | NEURONETICS ONE GREAT VALLEY PKWY. STE.2 Malvern, PA 19355 |
| Contact | Judy P Ways |
| Correspondent | Judy P Ways NEURONETICS ONE GREAT VALLEY PKWY. STE.2 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 | 2008-11-28 |
| Decision Date | 2008-12-16 |
| Summary: | summary |