K241943
- 510(k) number
- K241943
- Device name
- Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented Mask
- Applicant
- Sleepnet Corporation NH · US
- Product code
- CBK — Ventilator, Continuous, Facility Use
- Decision date
- 2024-08-28
- Date received
- 2024-07-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
510(k) Summary (official FDA PDF): K241943.pdf
Official FDA record: K241943
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.