510(k) K050597 ยท CBK Ventilator, Continuous, Facility Use
GE DATEX-OHMEDA ENGSTROM CARESTATION
| Applicant | Datex-Ohmeda, Inc., Madison WI, US |
| Decision | Substantially Equivalent, Mar 25, 2005 |
| Received | Mar 9, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K050597
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.