510(k) K253390 ยท OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph
SOMNUM (SOMNUM)
| Applicant | Honeynaps Co., Ltd., Seoul, KR |
| Decision | Substantially Equivalent, Jun 27, 2026 |
| Received | Sep 30, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253390
No recall in the FDA data names this 510(k).
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