K241288
- 510(k) number
- K241288
- Device name
- Noxturnal Web
- Applicant
- Nox Medical Ehf IS
- Product code
- OLV — Standard Polysomnograph With Electroencephalograph
- Decision date
- 2024-12-23
- Date received
- 2024-05-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
510(k) Summary (official FDA PDF): K241288.pdf
Official FDA record: K241288
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.