510(k) K112722 ยท BSZ Gas-Machine, Anesthesia
GE DATEX-OHMEDA AVANCE
| Applicant | Datex-Ohmeda, Inc., Madison WI, US |
| Decision | Substantially Equivalent, Dec 16, 2011 |
| Received | Sep 19, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112722
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 3, 2016 | GE Healthcare, LLC GE Healthcare, Avance, Avance CS2, Amingo. Terminated |
BSZ | None listed |
| Jan 21, 2016 | GE Medical Systems, LLC GE Healthcare, Aisys CS2,1011-9050-000;
Avance Amingo,1009-9002-000, & Avance CS2, 1009-9050-000.
The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and v Terminated |
BSZ | None listed |
| 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.