510(k) K050055 ยท BSZ Gas-Machine, Anesthesia
GE DATEX-OHMEDA AESTIVA/5 MRI ANESTHESIA SYSTEM
| Applicant | Datex-Ohmeda, Inc., Madison WI, US |
| Decision | Substantially Equivalent, Feb 4, 2005 |
| Received | Jan 11, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K050055
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 19, 2019 | GE Healthcare, LLC Aestiva MRI, Model Numbers:
a) 1006-9310-000
b) 1006-9110-000
c) 1006-9023-000
d) 1006-9028-000
e) 1006-9310-000-305077
f) 1006-9310-000-015243
g) 1006-9310-000-017602
h) 1006-9310-000-103785
I) 1006- Terminated |
BSZ | None listed |
| Jan 21, 2016 | GE Medical Systems, LLC GE Healthcare, Aestiva MRI, 1006-9310-000.
This version of the Datex-Ohmeda 7900 ventilator is used in Datex-Ohmeda Aestiva/5 anesthesia systems. It is a microprocessor based, electronically controlle Terminated |
BSZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.