510(k) K243851
- Device
- CHLOE BLAST
- Applicant
- Fairtility , Ltd.
- 510(k) number
- K243851
- Product code
- PBH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-08-15
- Date received
- 2024-12-16
- Regulation
- 884.6195
- Classification name
- Embryo Image Assessment System, Assisted Reproduction
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Maya Baranes Zeevi
- Address
- 8 Ha’Melacha St. Tel-Aviv IL 6721508 6721508
FDA Registration Numbers#
- 3042372505
- 3009107689
- 3042972064