510(k) K090892 ยท BSZ Gas-Machine, Anesthesia
GE DATEX-OHMEDA S/5 ADU CARESTATION
| Applicant | GE Healthcare Finland Oy, Madison WI, US |
| Decision | Substantially Equivalent, Apr 30, 2009 |
| Received | Mar 31, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K090892
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 3, 2013 | GE Healthcare, LLC Canister: CO2 canister with GE part numbers 1407-3200-000, 1407-7004-000, or M1084850.
Intended to provide general inhalation anesthesia and ventilatory support. Terminated |
BSZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.