K241830
- 510(k) number
- K241830
- Device name
- Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask
- Applicant
- Sleepnet Corporation NH · US
- Product code
- BZD — Ventilator, Non-Continuous (Respirator)
- Decision date
- 2024-10-18
- Date received
- 2024-06-24
- 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: K241830.pdf
Official FDA record: K241830
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.