BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    BT-1000

    K Number: K232991 · Decision Aug 28, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    4
    Applicant Total
    11
    Review Days
    341

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    Basic Information

    Device Name
    BT-1000
    K Number
    K232991
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5898
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bistos Co., Ltd.
    Date Received
    September 22, 2023
    Decision Date
    August 28, 2024
    Product Code
    QGL
    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
    QGL Transcutaneous Nerve Stimulator For Adhd

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