SOMNUM (SOMNUM)
Device Facts
| Record ID | K253390 |
|---|---|
| Device Name | SOMNUM (SOMNUM) |
| Applicant | Honeynaps Co., Ltd. |
| Product Code | OLZ · Neurology |
| Decision Date | Jun 27, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.1400 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.
