BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    BIOTRON 18

    K Number: K771534 · Decision Aug 26, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    18
    Applicant Total
    2
    Review Days
    16

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    Basic Information

    Device Name
    BIOTRON 18
    K Number
    K771534
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5800
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Biotronics Corp.
    Date Received
    August 10, 1977
    Decision Date
    August 26, 1977
    Product Code
    QJQ
    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
    QJQ Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety

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    Other Clearances by Biotronics Corp.

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