510(k) K993407 ยท FMZ Incubator, Neonatal
OHMEDA MEDICAL OMNIBED
| Applicant | Ohmeda Medical, Columbia MD, US |
| Decision | Substantially Equivalent, Jan 5, 2000 |
| Received | Oct 8, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993407
| 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 |
| Oct 5, 2018 | Ohmeda Medical Giraffe Omnibed - Product Usage: The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to Terminated |
FMZ | None listed |
| Nov 18, 2016 | Ohmeda Medical Giraffe OmniBed
Ohmeda Medical Omnibed- The OmniBed is a combination of an infant incubator ( incubator ) and an infant radiant warmer ( warmer ). Incubators and warmers provide heat in a controlled m 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.