510(k) K031387 ยท FMZ Incubator, Neonatal
ISOLETTE INFANT INCUBATOR, MODEL C2000E
| Applicant | Hill-Rom Manufacturing, Inc., Hatboro PA, US |
| Decision | Substantially Equivalent, Aug 1, 2003 |
| Received | May 2, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031387
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.