510(k) K140575 ยท CBK Ventilator, Continuous, Facility Use
ENGSTROM CARESTATION, ENGSTROM PRO
| Applicant | Datex-Ohmeda, Inc., Madison WI, US |
| Decision | Substantially Equivalent, Feb 3, 2015 |
| Received | Mar 6, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140575
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.