NEUROSTAR TMS SYSTEM
Transcranial Magnetic Stimulator
NEURONETICS
The following data is part of a De Novo classification by Neuronetics with the FDA for Neurostar Tms System.
Pre-market Notification Details
| 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 |
NIH GUDID Devices
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