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

    NH-2002

    K Number: K932050 · Decision Jun 5, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    18
    Applicant Total
    1
    Review Days
    769

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    Basic Information

    Device Name
    NH-2002
    K Number
    K932050
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5800
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    New Horizon Health Care
    Date Received
    April 27, 1993
    Decision Date
    June 5, 1995
    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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