K241469
- 510(k) number
- K241469
- Device name
- iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask
- Applicant
- Sleepnet Corporation NH · US
- Product code
- BZD — Ventilator, Non-Continuous (Respirator)
- Decision date
- 2024-06-15
- Date received
- 2024-05-24
- 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: K241469.pdf
Official FDA record: K241469
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.