Brainsway Deep TMS System
FDA 510(k) clearance K200957 · decided 2020-08-21
Clearance details
- K-number
- K200957
- Device name
- Brainsway Deep TMS System
- Applicant
- Brainsway , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2020-04-09
- Decision date
- 2020-08-21
- Days to decision
- 134 days
- Clearance type
- Traditional
- Product code
- QMD
- Device class
- 2
- Regulation number
- 882.5802
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Jerusalem, IL
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Brainsway Deep (DTMS) System (K203616) | Brainsway , Ltd. | 2021-04-16 |
Recalls involving this device
No recalls on record reference this clearance.