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

    SMARTWAVE IF 2000

    K Number: K003631 · Decision Aug 10, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    72
    Applicant Total
    3
    Review Days
    259

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    Basic Information

    Device Name
    SMARTWAVE IF 2000
    K Number
    K003631
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Newwave Medical, LLC
    Date Received
    November 24, 2000
    Decision Date
    August 10, 2001
    Product Code
    LIH
    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
    LIH Interferential Current Therapy

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    Other Clearances by Newwave Medical, LLC

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