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

    CHECKPOINT WITH ACCUSTIM TECHNOLOGY

    K Number: K061365 · Decision Jul 12, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    96
    Applicant Total
    3
    Review Days
    57

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    Basic Information

    Device Name
    CHECKPOINT WITH ACCUSTIM TECHNOLOGY
    K Number
    K061365
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.1820
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ndi Medical, LLC
    Date Received
    May 16, 2006
    Decision Date
    July 12, 2006
    Product Code
    ETN
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ETN Stimulator, Nerve

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    Other Clearances by Ndi Medical, LLC

    K Number Device Name
    K150005 Checkpoint, Checkpoint Head & Neck
    K092292 CHECKPOINT