K241288 is an FDA 510(k) clearance for the Noxturnal Web. This device is classified as a Standard Polysomnograph With Electroencephalograph (Class II - Special Controls, product code OLV).
Submitted by Nox Medical Ehf (Reykjavik, IS). The FDA issued a Cleared decision on December 23, 2024, 230 days after receiving the submission on May 7, 2024.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1400. Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain And Other Signals (such As Electromyography, Respiratory And/or Oximetry Signals) For Sleep Recordings. May Also Be Used To Allow On-screen Review, User-controlled Annotation And User-controlled Marking Of Data..
| 510(k) Number | K241288 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 07, 2024 |
| Decision Date | December 23, 2024 |
| Days to Decision | 230 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | OLV — Standard Polysomnograph With Electroencephalograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1400 |
| Definition | Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain And Other Signals (such As Electromyography, Respiratory And/or Oximetry Signals) For Sleep Recordings. May Also Be Used To Allow On-screen Review, User-controlled Annotation And User-controlled Marking Of Data. |