The following data is part of a De Novo classification by Neuronetics with the FDA for Neurostar Tms System.
| DeNovo ID | DEN070003 |
| Device Name: | NEUROSTAR TMS SYSTEM |
| Classification | Transcranial Magnetic Stimulator |
| Applicant | NEURONETICS one Great Valley Pkwy. ste.2 Malvern, PA 19355 |
| Contact | Judy P Ways |
| Product Code | OBP |
| CFR Regulation Number | 882.5805 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K061053 |
| Review Advisory Board | Neurology |
| Classification Advisory | Neurology |
| Type | Post-NSE |
| Date Received | 2007-05-24 |
| Decision Date | 2008-10-07 |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00869378000148 | DEN070003 | 000 |
| 00850005944041 | DEN070003 | 000 |
| 00850005944164 | DEN070003 | 000 |
| 00850005944171 | DEN070003 | 000 |
| 00850005944188 | DEN070003 | 000 |
| 10850005944222 | DEN070003 | 000 |
| 00850005944416 | DEN070003 | 000 |
| 00850005944492 | DEN070003 | 000 |
| 10850005944383 | DEN070003 | 000 |
| 00869378000100 | DEN070003 | 000 |
| 10850005944635 | DEN070003 | 000 |