510(k) K131945 ยท BSZ Gas-Machine, Anesthesia
GE DATEX-OHMEDA AVANCE CS2
| Applicant | Datex-Ohmeda, Madison WI, US |
| Decision | Substantially Equivalent, Aug 8, 2013 |
| Received | Jun 27, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K131945
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.