510(k) K103524 ยท FPL Incubator, Neonatal Transport
VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WITH NELLCOR PULSEOX
| Applicant | International Biomedical, Ltd., Austin TX, US |
| Decision | Substantially Equivalent, Apr 15, 2011 |
| Received | Dec 1, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K103524
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.