K240285
- 510(k) number
- K240285
- Device name
- Huxley SANSA Home Sleep Apnea Test (1000-00)
- Applicant
- Huxley Medical GA · US
- Product code
- MNR — Ventilatory Effort Recorder
- Decision date
- 2024-07-15
- Date received
- 2024-02-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K240285.pdf
Official FDA record: K240285
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.