BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    CHLOE BLAST

    K Number: K243851 · Decision Aug 15, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    4
    Applicant Total
    1
    Review Days
    242

    Basic Information

    Device Name
    CHLOE BLAST
    K Number
    K243851
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.6195
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fairtility , Ltd.
    Date Received
    December 16, 2024
    Decision Date
    August 15, 2025
    Product Code
    PBH
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PBH Embryo Image Assessment System, Assisted Reproduction

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