510(k) K190533 ยท CBK Ventilator, Continuous, Facility Use
Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Full Face AAV Non-Vented
| Applicant | Sleepnet Corporation, Hampton NH, US |
| Decision | Substantially Equivalent, Jul 26, 2019 |
| Received | Mar 4, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190533
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 1, 2024 | SleepNet Corporation Mojo 2 Full Face Non Vented Mask, All Sizes Open, Classified |
BZD | None listed |
| Apr 1, 2024 | SleepNet Corporation Mojo 2 Full Face AAV Non Vented Mask, All Sizes Open, Classified |
BZD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.