The following data is part of a premarket notification filed by Brainsway Ltd. with the FDA for Brainsway Deep Tms System.
| Device ID | K203735 |
| 510k Number | K203735 |
| Device Name: | Brainsway Deep TMS System |
| Classification | Transcranial Magnetic Stimulator |
| Applicant | Brainsway Ltd. 19 Hartom St. (Bynet Bldg) Har Hotzvim Jerusalem, IL 9777518 |
| Contact | Ahava Stein |
| Correspondent | Ahava Stein A. Stein - Regulatory Affairs Consulting Ltd. 20 Hata'as Str., Suite 102 Kfar Saba, IL 4442520 |
| Product Code | OBP |
| CFR Regulation Number | 882.5805 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-21 |
| Decision Date | 2021-04-23 |