510(k) K020547 ยท FMZ Incubator, Neonatal
OHMEDA MEDICAL GIRAFFE INCUBATOR
| Applicant | Ohmeda Medical, Laurel MD, US |
| Decision | Substantially Equivalent, May 9, 2002 |
| Received | Feb 19, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020547
| 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
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 t 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 |
| Jul 29, 2003 | Ohmeda Medical, A division of Datex-Ohmeda, Inc. Servo Controlled Oxygen System for Ohmeda''s Medical Giraffe OmniBed and Ohmeda''s Medical Girraffe Incubators Terminated |
80F | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.