The following data is part of a premarket notification filed by Teleemg, Llc with the FDA for Neurosoft Tms.
| Device ID | K160309 |
| 510k Number | K160309 |
| Device Name: | Neurosoft TMS |
| Classification | Transcranial Magnetic Stimulator |
| Applicant | TeleEMG, LLC 27 Arlington Rd., Building 2, Unit 1 Woburn, MA 01801 |
| Contact | Joe F Jabre |
| Correspondent | Barry Ashar Makromed, Inc. 88 Stiles Road Salem, NH 03079 |
| Product Code | OBP |
| CFR Regulation Number | 882.5805 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-04 |
| Decision Date | 2016-12-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04650075330197 | K160309 | 000 |