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

    LISS CRANIAL STIMULATOR MODEL SBL201-M

    K Number: K894515 · Decision May 3, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    18
    Applicant Total
    6
    Review Days
    288

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    Basic Information

    Device Name
    LISS CRANIAL STIMULATOR MODEL SBL201-M
    K Number
    K894515
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5800
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Medical Consultants Intl. , Ltd.
    Date Received
    July 19, 1989
    Decision Date
    May 3, 1990
    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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    K903654 LISS CRANIAL STIMULATOR MODEL SBL202-B
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