- Device
- SOMNUM (SOMNUM)
- Company
- Honeynaps Co., Ltd.
- Submission number
- K253390
- Pathway
- 510(k)
- Decision date
- Jun 27, 2026
- Specialty (lead panel)
- Neurology
- Primary product code
- OLZ
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.