SOMNUM (SOMNUM)— 510(k) K253390
Substantially EquivalentHoneynaps Co., Ltd.
FDA 510(k) clearance K253390 for SOMNUM (SOMNUM), Substantially Equivalent on 2026-06-27. Applicant: Honeynaps Co., Ltd.. Device class: 2.
Summary
Honeynaps' SOMNUM is filed under OLZ, automatic event detection software for polysomnographs with electroencephalographs. The record doesn't describe SOMNUM beyond its name and the code name.
Class II, 21 CFR 882.1400. Neurology is both the classification panel and the review panel. The submission was a Traditional 510(k).
Honeynaps filed from Seoul, South Korea. The decision came 270 calendar days after FDA received it (September 30, 2025 to June 27, 2026).
Clearance details
- Applicant
- Honeynaps Co., Ltd.
- Product code
- Product code OLZ
- Device class
- Class 2
- Regulation
- 21 CFR 882.1400
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seoul, KR
Recent devices under product code OLZ
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