510(k) K060862 ยท CBK Ventilator, Continuous, Facility Use
GE DATEX-OHMEDA ENGSTROM CARESTATION
| Applicant | Datex-Ohmeda, Inc., Madison WI, US |
| Decision | Substantially Equivalent, Jun 5, 2006 |
| Received | Mar 29, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060862
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 10, 2007 | Datex - Ohmeda, Inc GE Healthcare Engstrom Carestation Critical Care Ventilator with the High Performance Display Unit with SW version 3.x and 4.11; identification numbers 1505-9000-000 and M1057699 (upgrade). Datex-Ohm Terminated |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.