510(k) K243372 ยท LBI Unit, Neonatal Phototherapy
BiliWrap
| Applicant | Gerium Medical, Ltd., Yavne, IL |
| Decision | Substantially Equivalent, May 29, 2025 |
| Received | Oct 30, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243372
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.