BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇮 Finland

    Bindex BI-2

    K Number: K211350 · Decision Apr 29, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    8
    Applicant Total
    3
    Review Days
    361

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    Basic Information

    Device Name
    Bindex BI-2
    K Number
    K211350
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1180
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bone Index Finland , Ltd.
    Date Received
    May 3, 2021
    Decision Date
    April 29, 2022
    Product Code
    MUA
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MUA Bone Sonometer

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    ACHILLES

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    Other Clearances by Bone Index Finland , Ltd.

    K Number Device Name
    K161971 Bindex BI-2
    K152020 Bindex BI-100