BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇷 Türkiye

    Parky App

    K Number: K220820 · Decision Nov 17, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    12
    Applicant Total
    1
    Review Days
    241

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    Basic Information

    Device Name
    Parky App
    K Number
    K220820
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1950
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    H2o Bilisim Yazilim
    Date Received
    March 21, 2022
    Decision Date
    November 17, 2022
    Product Code
    GYD
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GYD Transducer, Tremor

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