K252330
- 510(k) number
- K252330
- Device name
- DeepRESP
- Applicant
- Nox Medical Ehf IS
- Product code
- OLZ — Automatic Event Detection Software For Polysomnograp
- Decision date
- 2025-11-17
- Date received
- 2025-07-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K252330.pdf
Official FDA record: K252330
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.