510(k) K081842 ยท CBK Ventilator, Continuous, Facility Use
ENGSTROM CARESTATION, ENGSTROM PRO
| Applicant | Datex-Ohmeda, Inc., Madison WI, US |
| Decision | Substantially Equivalent, Oct 3, 2008 |
| Received | Jun 30, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081842
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.