510(k) K063806 ยท CBK Ventilator, Continuous, Facility Use
SLEEPNET MOJO -NV FULL FACE MASK, NON-VENTED
| Applicant | Sleepnet Corporation, Manchester NH, US |
| Decision | Substantially Equivalent, May 17, 2007 |
| Received | Dec 22, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063806
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 1, 2024 | SleepNet Corporation Mojo Non Vented Full Face Mask with Headgear, 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.