K244027
- 510(k) number
- K244027
- Device name
- SANSA HSAT
- Applicant
- Huxley Medical GA · US
- Product code
- MNR — Ventilatory Effort Recorder
- Decision date
- 2025-01-28
- Date received
- 2024-12-30
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K244027.pdf
Official FDA record: K244027
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.