510(k) K243851 ยท PBH Embryo Image Assessment System, Assisted Reproduction
CHLOE BLAST
| Applicant | Fairtility , Ltd., Tel-Aviv, IL |
| Decision | Substantially Equivalent, Aug 15, 2025 |
| Received | Dec 16, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243851
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.