510(k) K974349 ยท FMZ Incubator, Neonatal
OHMEDA-OHIO CARE PLUS INCUBATOR
| Applicant | Ohmeda Medical, Columbia MD, US |
| Decision | Substantially Equivalent, Feb 12, 1998 |
| Received | Nov 19, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974349
| 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 |
| Nov 18, 2016 | Ohmeda Medical CarePlus Incubator
Ohmeda-Ohio CarePlus Incubator- Incubators provide a controlled thermal environment for neonates who are unable to provide their own thermoregulation. They may also be used for shor Terminated |
FMZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.