K241661
- 510(k) number
- K241661
- Device name
- Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented Mask
- Applicant
- Sleepnet Corporation NH · US
- Product code
- BZD — Ventilator, Non-Continuous (Respirator)
- Decision date
- 2024-07-10
- Date received
- 2024-06-10
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Anesthesiology
510(k) Summary (official FDA PDF): K241661.pdf
Official FDA record: K241661
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.