The following data is part of a premarket notification filed by Neuronetics, Inc. with the FDA for Neurostar Advanced Therapy.
| Device ID | K201158 |
| 510k Number | K201158 |
| Device Name: | NeuroStar Advanced Therapy |
| Classification | Transcranial Magnetic Stimulator |
| Applicant | Neuronetics, Inc. 3222 Phoenixville Pike Malvern, PA 19355 |
| Contact | Gary Johnson |
| Correspondent | Gary Johnson 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 | 2020-04-30 |
| Decision Date | 2020-11-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850005944591 | K201158 | 000 |
| 00850005944096 | K201158 | 000 |
| 00850005944102 | K201158 | 000 |
| 00850005944126 | K201158 | 000 |
| 00850005944133 | K201158 | 000 |
| 00850005944515 | K201158 | 000 |
| 00850005944089 | K201158 | 000 |
| 00850005944119 | K201158 | 000 |
| 00850005944508 | K201158 | 000 |
| 00850005944522 | K201158 | 000 |
| 00850005944577 | K201158 | 000 |
| 00850005944584 | K201158 | 000 |
| 00850005944430 | K201158 | 000 |