510(k) K110550 ยท LBI Unit, Neonatal Phototherapy
BRIGHT EMBRACE MODEL SBL60
| Applicant | Physician Engineered Products, Inc., Fryeburg ME, US |
| Decision | Substantially Equivalent, Feb 3, 2012 |
| Received | Feb 25, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110550
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 31, 2015 | Physician Engineered Products, Inc. Bright Embrace, a Single Bili Light for newborn phototherapy
Distributed by: Physician Engineered Products, Inc., Model SBL60 Terminated |
LBI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.