510(k) K053168 ยท MNS Ventilator, Continuous, Non-Life-Supporting
BIPAP FOCUS
| Applicant | Respironics (Ireland) Limited, Galway, IE |
| Decision | Substantially Equivalent, Jan 4, 2006 |
| Received | Nov 14, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053168
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 7, 2009 | Respironics California Inc Respironics BiPAP Focus Noninvasive Ventilator System.
The BiPAP Focus is a non-invasive, pressure support ventilator used to augment the breathing of patients suffering from acute or chronic respira Terminated |
MNS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.