510(k) K122445 ยท BSZ Gas-Machine, Anesthesia
AESPIRE 7900, AESPIRE VIEW
| Applicant | Datex-Ohmeda, Madison WI, US |
| Decision | Substantially Equivalent, Oct 12, 2012 |
| Received | Aug 10, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K122445
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 21, 2016 | GE Medical Systems, LLC GE Healthcare, Aespire 7900, 1009-9012-000 &
Aespire View, 1009-9212-000.
The family of GE Datex-Ohmeda Aespire anesthesia systems with 7900 ventilator (Aespire 7900 and Aespire View) is intended to Terminated |
BSZ | None listed |
| Apr 2, 2015 | GE Healthcare GE Healthcare, Aespire 7900, Aespire View Anesthesia Machines. Model numbers 1009-9012-000.
Intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients 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 |
| 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.