K250882
- 510(k) number
- K250882
- Device name
- SANSA HSAT
- Applicant
- Huxley Medical GA · US
- Product code
- MNR — Ventilatory Effort Recorder
- Decision date
- 2025-10-29
- Date received
- 2025-03-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K250882.pdf
Official FDA record: K250882
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.