The following data is part of a premarket notification filed by Soterix Medical, Inc. with the FDA for Mega-tms.
| Device ID | K192823 |
| 510k Number | K192823 |
| Device Name: | MEGA-TMS |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | Soterix Medical, Inc. 237 W 35 ST, 1401 New York, NY 10001 |
| Contact | Abhishek Datta |
| Correspondent | Abhishek Datta Soterix Medical, Inc. 237 W 35 ST, 1401 New York, NY 10001 |
| Product Code | GWF |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-02 |
| Decision Date | 2021-08-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04650075333174 | K192823 | 000 |