- Device
- MeRT System
- Company
- Wave Neuroscience
- Submission number
- K260402
- Pathway
- 510(k)
- Decision date
- Jun 3, 2026
- Specialty (lead panel)
- Neurology
- Primary product code
- SIG
Source: U.S. FDA AI-Enabled Medical Devices list. The FDA says the list is not comprehensive. Confirm details on the FDA's own record.