Mojo 2 Full Face Non-Vented Mask +3 more— 510(k) K241520
Substantially EquivalentSleepnet Corporation
FDA 510(k) clearance K241520 for Mojo 2 Full Face Non-Vented Mask +3 more, Substantially Equivalent on 2024-06-27. Applicant: Sleepnet Corporation. Device class: 2.
Clearance details
- Device name as filed
- 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
- Product code
- Code CBK
- Device class
- Class 2
- Regulation
- 21 CFR 868.5895
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Hampton, NH, US
Recent devices under product code CBK
view allMore clearances from Sleepnet Corporation
view all- K251847 — Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask
- K241830 — Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask
- K241943 — Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented Mask
- K241661 — Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented Mask
- K241469 — iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask
Adverse events under product code CBK
product code CBK- Death
- 736
- Injury
- 3,628
- Malfunction
- 98,786
- Other
- 4
- Total
- 103,154
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.