K251847
- 510(k) number
- K251847
- Device name
- Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask
- Applicant
- Sleepnet Corporation NH · US
- Product code
- BZD — Ventilator, Non-Continuous (Respirator)
- Decision date
- 2026-01-15
- Date received
- 2025-06-16
- 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: K251847.pdf
Official FDA record: K251847
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.