The following data is part of a premarket notification filed by Brainsway, Ltd with the FDA for Brainsway Deep Tms System.
| Device ID | K122288 |
| 510k Number | K122288 |
| Device Name: | BRAINSWAY DEEP TMS SYSTEM |
| Classification | Transcranial Magnetic Stimulator |
| Applicant | BRAINSWAY, LTD 20 HATA'AS ST. (POB 124) Kfar Saba, IL 44425 |
| Contact | Ahava Stein |
| Correspondent | Ahava Stein BRAINSWAY, LTD 20 HATA'AS ST. (POB 124) Kfar Saba, IL 44425 |
| Product Code | OBP |
| CFR Regulation Number | 882.5805 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-30 |
| Decision Date | 2013-01-07 |
| Summary: | summary |