QMD
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Transcranial Magnetic Stimulation System For Smoking Cessation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.5802
- Medical specialty
- Neurology
- FDA definition
- Intended for use as a transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions.
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| Record | Firm | Date |
|---|---|---|
| Brainsway Deep (DTMS) System (K203616) | Brainsway , Ltd. | 2021-04-16 |
| Brainsway Deep TMS System (K200957) | Brainsway , Ltd. | 2020-08-21 |
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