The following data is part of a premarket notification filed by Neuronetics with the FDA for Neurostar Tms Therapy System.
| Device ID | K130233 |
| 510k Number | K130233 |
| Device Name: | NEUROSTAR TMS THERAPY SYSTEM |
| Classification | Transcranial Magnetic Stimulator |
| Applicant | NEURONETICS 31 GENERAL WARREN BLVD Malvern, PA 19355 -1245 |
| Contact | Judy P Ways, Ph.d. |
| Correspondent | Judy P Ways, Ph.d. NEURONETICS 31 GENERAL WARREN BLVD Malvern, PA 19355 -1245 |
| Product Code | OBP |
| CFR Regulation Number | 882.5805 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-30 |
| Decision Date | 2013-04-30 |
| Summary: | summary |