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

    TRANSCRANIAL ELECTROTHERAPY STIMULATOR-A, MODEL TESA-1

    K Number: K024377 · Decision Jul 21, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    18
    Applicant Total
    1
    Review Days
    202

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    Basic Information

    Device Name
    TRANSCRANIAL ELECTROTHERAPY STIMULATOR-A, MODEL TESA-1
    K Number
    K024377
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5800
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kalaco Scientific, Inc.
    Date Received
    December 31, 2002
    Decision Date
    July 21, 2003
    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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