510(k) K023366 ยท CBK Ventilator, Continuous, Facility Use
DATEX-OHMEDA 7900 VENTILATOR ENHANCEMENTS
| Applicant | Datex-Ohmeda, Inc., Madison WI, US |
| Decision | Substantially Equivalent, Oct 7, 2003 |
| Received | Oct 8, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023366
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 19, 2019 | GE Healthcare, LLC Aestiva 7900, Model Numbers:
a) 1006-9300-000
b) 1006-9305-000
c) 1006-9118-000
d) 1006-9112-000
e) 1006-9113-000
f) 1006-9020-000
g) 1006-9033-000
h) 1006-9117-000
i) 1006-9119-000
j) 1006-90 Terminated |
CBK | None listed |
| Jan 21, 2016 | GE Medical Systems, LLC GE Healthcare, Aestiva 7900, 1006-9305-000.
This version of the Datex-Ohmeda 7900 ventilator is used in Datex-Ohmeda Aestiva/5 anesthesia systems. It is a microprocessor based, electronically controll Terminated |
CBK | None listed |
| Jun 17, 2012 | GE Healthcare, LLC GE Healthcare, Aestiva/5 7900 SmartVent, anesthesia machine. Used in Datex-Ohmeda Aestiva/5 Anesthesia Systems. Terminated |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.