510(k) K120463 ยท BZD Ventilator, Non-Continuous (Respirator)
MOJO, VERASEAL
| Applicant | Sleepnet Corporation, Bonita Springs FL, US |
| Decision | Substantially Equivalent, Jul 27, 2012 |
| Received | Feb 15, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120463
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 1, 2024 | SleepNet Corporation Mojo Full Face 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.