510(k) K834335 ยท LBI Unit, Neonatal Phototherapy
AMEDA PHOTOTHERAPY LAMP FOR NEWBORN
| Applicant | Egnell, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Apr 20, 1984 |
| Received | Dec 12, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K834335
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.