510(k) K062710 ยท CBK Ventilator, Continuous, Facility Use
GE DATEX-OHMEDA ENGSTROM CARESTATION
| Applicant | Datex-Ohmeda, Inc., Madison WI, US |
| Decision | Substantially Equivalent, Dec 8, 2006 |
| Received | Sep 11, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062710
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 24, 2008 | GE Healthcare GE Datex-Ohmeda Engstrom Carestation The Carestation consists of three main components: a display, a ventilator unit, and an optional module bay. The display allows the user to interface with the sys Terminated |
CBK | None listed |
| Aug 16, 2008 | Datex - Ohmeda, Inc GE Datex-Ohmeda Neonatal Enhancement for the Engstrom Carestation, Model # 1505-3272-00, GE Healthcare P.O. Box 7550, Madison, WI 53707-7550, USA
Intended to provide mechanical ventilation for adul Terminated |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.