510(k) K871399 ยท FMZ Incubator, Neonatal
OHIO(R) CARE PLUS INCUBATOR
| Applicant | Ohmeda Medical, Columbia MD, US |
| Decision | Substantially Equivalent, Jun 5, 1987 |
| Received | Apr 7, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K871399
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 9, 2024 | Wipro GE Healthcare Private Ltd. GE Healthcare neonatal incubator, models:
a) Care Plus,
b) Care Plus 1000,
c) Care Plus 2000,
d) Care Plus 3000,
e) Care Plus 4000, Plus 4000 Open, Classified |
FMZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.