510(k) K001242 ยท FMZ Incubator, Neonatal
ISOLETTE INFANT INCUBATOR, MODEL C2HS
| Applicant | Hill-Rom Air-Shields, Hatboro PA, US |
| Decision | Substantially Equivalent, Jul 13, 2000 |
| Received | Apr 18, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001242
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.