510(k) K120820 ยท LBI Unit, Neonatal Phototherapy
GIRAFFE BLUE SPOT PT LITE
| Applicant | Lumitex, Inc., Strongsville OH, US |
| Decision | Substantially Equivalent, Jun 8, 2012 |
| Received | Mar 19, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120820
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 11, 2019 | Lumitex Inc Giraffe Blue Spot PT LiteTM Phototherapy System, Model Numbers M1224917, M1231533, M1225025, M1224961, M1224958, M1224957, M1224959, M1224963, M1225773, M1225066, M1224960, M1225059, M1225023, M122506 Terminated |
LBI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.