K243851
- 510(k) number
- K243851
- Device name
- CHLOE BLAST
- Applicant
- Fairtility , Ltd. IL
- Product code
- PBH — Embryo Image Assessment System, Assisted Reproductio
- Decision date
- 2025-08-15
- Date received
- 2024-12-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K243851.pdf
Official FDA record: K243851
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.