510(k) K103589 ยท LBI Unit, Neonatal Phototherapy
NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM
| Applicant | Natus Medical Incorporated, Seattle WA, US |
| Decision | Substantially Equivalent, May 13, 2011 |
| Received | Dec 7, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103589
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 15, 2016 | Natus Medical Incorporated Updated Natus neoBLUE blanket LED Phototherapy Systems. It provides phototherapy underneath the infant and can be used in a bassinet, open bed, radiant warmer, incubator, or while holding the infant. Terminated |
LBI | None listed |
| Oct 28, 2016 | Natus Medical Incorporated Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia.
006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad Terminated |
LBI | None listed |
| Apr 10, 2015 | Natus Medical Incorporated Natus neoBLUE blanket LED Phototherapy system which includes the following items:
006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad
006254 neoBLUE blanket LED Light Box
006895 Terminated |
LBI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.