510(k) K210289 ยท LBI Unit, Neonatal Phototherapy
Infant Phototherapy Equipment
| Applicant | Bistos Co., Ltd., Seongnam-Si, KR |
| Decision | Substantially Equivalent, May 28, 2021 |
| Received | Feb 2, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210289
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.