BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇧🇪 Belgium

    Bloomlife MFM-Pro

    K Number: K222327 · Decision Feb 13, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    213
    Applicant Total
    1
    Review Days
    195

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    Basic Information

    Device Name
    Bloomlife MFM-Pro
    K Number
    K222327
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2740
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bloom Technologies NV
    Date Received
    August 2, 2022
    Decision Date
    February 13, 2023
    Product Code
    HGM
    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
    HGM System, Monitoring, Perinatal

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