510(k) K010222 ยท FMZ Incubator, Neonatal
OHMEDA MEDICAL GIRAFFE INCUBATOR
| Applicant | Ohmeda Medical, Laurel MD, US |
| Decision | Substantially Equivalent, Mar 21, 2001 |
| Received | Jan 24, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010222
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 28, 2020 | GE Healthcare, LLC Giraffe Incubator with installed Servo Oxygen module. Infant incubator. Terminated |
FMZ | None listed |
| Nov 18, 2016 | Ohmeda Medical Giraffe Incubator
The Giraffe Incubator is an infant incubator. Incubators provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Incubators p Terminated |
FMZ | None listed |
| Jul 28, 2005 | Ohmeda Medical, A division of Datex-Ohmeda, Inc. Ohmeda Medical''s Giraffe OmniBeds and Giraffe Incubators Terminated |
FMZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.