The following data is part of a premarket notification filed by Brainsway Ltd. with the FDA for Brainsway Deep Tms System.
| Device ID | K183303 |
| 510k Number | K183303 |
| Device Name: | Brainsway Deep TMS System |
| Classification | Transcranial Magnetic Stimulation System For Obsessive-compulsive Disorder |
| Applicant | Brainsway Ltd. 19 Hartom St. (Bynet Bldg) Har Hotzvim Jerusalem, IL 9777518 |
| Contact | Moria Ankri |
| Correspondent | Janice M. Hogan Hogan Lovells US LLP 1735 Market St., 23rd Floor Philadelphia, PA 19103 |
| Product Code | QCI |
| CFR Regulation Number | 882.5802 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-27 |
| Decision Date | 2019-03-08 |