510(k) K130178 ยท CBK Ventilator, Continuous, Facility Use
INSPIRATION VENTILATOR SYSTEM 5I/7I
| Applicant | eVent Medical, Ltd., San Clemente CA, US |
| Decision | Substantially Equivalent, Oct 29, 2013 |
| Received | Jan 25, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130178
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 19, 2015 | Event Medical LTD Inspiration Ventilator System, i Series and LS 12.1 LCD. The Inspiration 7i / 5i Ventilator System is to be used by healthcare professionals in hospitals or healthcare facilities and intra-hospital Terminated |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.