The following data is part of a premarket notification filed by Brainsway Ltd. with the FDA for Brainsway Deep (dtms) System.
| Device ID | K173540 |
| 510k Number | K173540 |
| Device Name: | Brainsway Deep (DTMS) System |
| Classification | Transcranial Magnetic Stimulator |
| Applicant | Brainsway Ltd. 19 Hartom Str. Jerusalem, IL 9777518 |
| Contact | Ahava Stein |
| Correspondent | Ahava Stein A. Stein Regulatory Affairs Consulting Ltd. 20 Hataas St., 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 | 2017-11-15 |
| Decision Date | 2018-05-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290110538057 | K173540 | 000 |
| 07290110538026 | K173540 | 000 |
| 07290110537234 | K173540 | 000 |
| 07290110533106 | K173540 | 000 |
| 07290110533090 | K173540 | 000 |
| 07290110533083 | K173540 | 000 |
| 07290110530136 | K173540 | 000 |