510(k) K123144 ยท NOU Continuous, Ventilator, Home Use
VIVO 50
| Applicant | Ge Healthcare, Breas Medical AB, Molnlycke, SE |
| Decision | Substantially Equivalent, Jun 18, 2013 |
| Received | Oct 5, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123144
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 16, 2015 | Breas Medical AB Breas Vivo 50 Home Care Ventilator
Product Usage:
Respiratory Care Terminated |
NOU | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.