510(k) K122715 ยท MNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator
STELLAR 150
| Applicant | Resmed Germany, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jun 17, 2013 |
| Received | Sep 5, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122715
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 12, 2019 | ResMed Ltd. ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150 Completed |
MNT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.