510(k) K011549 ยท LBI Unit, Neonatal Phototherapy
OHMEDA MEDICAL SPOT PT LITE PHOTOTHERAPY SYSTEM
| Applicant | Ohmeda Medical, Laurel MD, US |
| Decision | Substantially Equivalent, Jul 19, 2001 |
| Received | May 18, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011549
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 18, 2016 | Ohmeda Medical Giraffe Spot PT
Ohmeda Medical Spot PT Lite Phototherapy System- The Spot PT Lite Phototherapy System provides light therapy for the treatment of hyperbilirubinemia, commonly known as neonatal jaundic Terminated |
LBI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.