510(k) K053568 ยท LBI Unit, Neonatal Phototherapy
BILISOFT PHOTOTHERAPY SYSTEM
| Applicant | Lumitex, Inc., Strongsville OH, US |
| Decision | Substantially Equivalent, Apr 17, 2006 |
| Received | Dec 22, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053568
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.