510(k) K132530 ยท BSZ Gas-Machine, Anesthesia
GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2)
| Applicant | Datex-Ohmeda, Inc., Madison WI, US |
| Decision | Substantially Equivalent, Dec 20, 2013 |
| Received | Aug 12, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132530
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 15, 2016 | GE Medical Systems, LLC GE Healthcare, Aisys and Aisys CS2.
Intended to provide general inhalation anesthesia and ventilator support to a wide range of patients (neonatal, pediatric, and adult). Terminated |
BSZ | None listed |
| Feb 17, 2016 | GE Medical Systems, LLC GE Healthcare, Aisys CS2 anesthesia.. 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.