K251165
- 510(k) number
- K251165
- Device name
- Saans (F4-01-00-000-000)
- Applicant
- Innaccel Technologies Private Limited IN
- Product code
- SGR — Noninvasive Positive Airway Pressure System, Facilit
- Decision date
- 2026-01-06
- Date received
- 2025-04-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K251165.pdf
Official FDA record: K251165
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.