DeepRESP (Nox Medical Ehf) was cleared through 510(k) (substantially equivalent) by FDA on Nov 17, 2025 under submission K252330, product code OLZ. Review panel: Neurology.
| FDA submission number | K252330 |
|---|---|
| Pathway | 510(k) |
| Company | Nox Medical Ehf |
| Review panel (specialty) | Neurology |
| FDA decision date | 2025-11-17 |
| Decision | Substantially Equivalent |
| Product code | OLZ |
| Classification | Automatic Event Detection Software For Polysomnograph With Electroencephalograph |
| Device class | Class II |
| Regulation number | 882.1400 |
| Review time (calendar days) | 115 |
| Applicant country | IS |
Official FDA database record (decision summary) · FDA AI-enabled device list
FAQ
Is DeepRESP FDA authorized?
Yes. DeepRESP appears on FDA's AI-enabled medical device list. It was cleared through 510(k) (substantially equivalent) on Nov 17, 2025 (K252330).
Which FDA pathway was used for DeepRESP?
510(k), submission number K252330, decision: Substantially Equivalent, after 115 calendar days of review.
What is the FDA product code for DeepRESP?
OLZ (Automatic Event Detection Software For Polysomnograph With Electroencephalograph), Class II, regulation 882.1400.
Other AI devices with product code OLZ
- SOMNUM (SOMNUM) (Honeynaps Co., Ltd., K253390, Jun 27, 2026)
- Onera SleepMap (SLEEPMAP) (Onera B.V., K253668, Mar 8, 2026)
- DeepRESP (Nox Medical ehf, K241960, Mar 14, 2025)
- Dreem 3S (Beacon Biosignals, Inc., K242094, Nov 22, 2024)
- SleepStageML (Beacon Biosignals, Inc., K233438, Mar 8, 2024)
- Dreem 3S (Beacon Biosignals, Inc., K223539, Aug 18, 2023)
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More from Nox Medical Ehf
- DeepRESP (Nox Medical ehf, K241960, Mar 14, 2025)
All Neurology AI devices · Full device index
Data as of: FDA AI-enabled device list through Jun 29, 2026, joined to openFDA. Informational only; verify against the FDA record.