Huxley Medical · Class II · Cleared Jul 15, 2024
| K-number | K240285 |
| Device name | Huxley SANSA Home Sleep Apnea Test (1000-00) |
| Applicant | Huxley Medical |
| Product code | MNR |
| Device class | Class II |
| Decision date | Jul 15, 2024 |
| Decision | Substantially Equivalent |
| Regulation | 868.2375 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov