The following data is part of a premarket notification filed by Neuronetics, Inc. with the FDA for Neurostar Tms Therapy System.
| Device ID | K161519 |
| 510k Number | K161519 |
| Device Name: | NeuroStar TMS Therapy System |
| Classification | Transcranial Magnetic Stimulator |
| Applicant | NEURONETICS, INC. 3222 PHOENIXVILLE PIKE Malvern, PA 19355 |
| Contact | Judy P. Ways |
| Correspondent | Judy P. Ways NEURONETICS, INC. 3222 PHOENIXVILLE PIKE Malvern, PA 19355 |
| Product Code | OBP |
| CFR Regulation Number | 882.5805 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-02 |
| Decision Date | 2016-09-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850005944232 | K161519 | 000 |
| 10850005944215 | K161519 | 000 |
| 00850005944652 | K161519 | 000 |
| 00869378000117 | K161519 | 000 |