K241520
- 510(k) number
- K241520
- Device name
- Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full Face Non-Vented Mask; Veraseal 3 Full Face AAV Non-Vented Mask
- Applicant
- Sleepnet Corporation NH · US
- Product code
- CBK — Ventilator, Continuous, Facility Use
- Decision date
- 2024-06-27
- Date received
- 2024-05-29
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K241520.pdf
Official FDA record: K241520
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.