510(k) K213553 ยท FMZ Incubator, Neonatal
Giraffe Incubator Carestation CS1
| Applicant | Datex Ohmeda, Inc., Wauwatosa WI, US |
| Decision | Substantially Equivalent, Mar 2, 2022 |
| Received | Nov 8, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213553
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.