510(k) K152809 ยท FMZ Incubator, Neonatal
Giraffe Incubator Carestation CS1
| Applicant | Ohmeda Medical, A Division of Datex-Ohmeda, Inc., Laurel MD, US |
| Decision | Substantially Equivalent, Dec 31, 2015 |
| Received | Sep 28, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K152809
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 31, 2024 | DATEX--OHMEDA, INC. GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers:
1) 2082844-002-01040417;
2) 2082844-002-01044956;
3) 2082844-002-01058424;
4) 2082844-002-01069017;
5) 2082844-0 Completed |
FMZ | None listed |
| Dec 3, 2019 | GE Healthcare, LLC Giraffe Incubator Carestation, Giraffe Incubator Carestation CS1 infant warmer Terminated |
FMT | None listed |
| Sep 25, 2018 | GE Healthcare, LLC Giraffe Incubator Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestation CS1 Terminated |
FMZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.