FDA AI Clearance Tracker/K240285
Anesthesiology · 510(k)
Huxley SANSA Home Sleep Apnea Test (1000-00)
Huxley Medical
About this listing
Huxley SANSA Home Sleep Apnea Test (1000-00) from Huxley Medical appears on the U.S. FDA list of AI-enabled medical devices under submission K240285. It went through the 510(k) pathway, reviewed by the Anesthesiology panel, with an FDA decision dated July 15, 2024. Its primary FDA product code is MNR.
The FDA list records the regulatory facts above. For the device's cleared intended use, read the FDA decision summary linked at the bottom of this page.
- Device
- Huxley SANSA Home Sleep Apnea Test (1000-00)
- Company
- Huxley Medical
- Submission number
- K240285
- Pathway
- 510(k)
- Decision date
- Jul 15, 2024
- Specialty (lead panel)
- Anesthesiology
- Primary product code
- MNR
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Source: U.S. FDA AI-Enabled Medical Devices list. The FDA says the list is not comprehensive. Confirm details on the FDA's own record.