510(k) K101778 ยท FMZ Incubator, Neonatal
GIRAFFE INCUBATOR
| Applicant | Ohmeda Medical, Laurel MD, US |
| Decision | Substantially Equivalent, Jul 21, 2010 |
| Received | Jun 25, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K101778
| 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 |
| Apr 5, 2013 | GE Healthcare, LLC Giraffe OmniBed and Giraffe Incubator p/n 6600-0723-700 (rev A and B) labeled in part: ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 U.S.A. www.gehealthcare.com***.
GE Healthcare Giraffe Omnib Terminated |
FMZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.