510(k) K123125 ยท BSZ Gas-Machine, Anesthesia
GE DATEX-OHMEDA AVANCE CS2
| Applicant | Datex-Ohmeda, Inc., Madison WI, US |
| Decision | Substantially Equivalent, Feb 6, 2013 |
| Received | Oct 4, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K123125
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 15, 2013 | GE Healthcare, LLC GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom.
Intended for volume or pressure control ventilation. Terminated |
BSZ | None listed |
| Oct 15, 2013 | GE Healthcare, LLC GE Healthcare, Aisys, Amingo, Avance, and Avance CS2.
Intended for volume or pressure control ventilation. Terminated |
BSZ | None listed |
| 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.