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

    Checkpoint, Checkpoint Head & Neck

    K Number: K150005 · Decision Feb 19, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    96
    Applicant Total
    3
    Review Days
    48

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    Basic Information

    Device Name
    Checkpoint, Checkpoint Head & Neck
    K Number
    K150005
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    874.1820
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ndi Medical, LLC
    Date Received
    January 2, 2015
    Decision Date
    February 19, 2015
    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
    K092292 CHECKPOINT
    K061365 CHECKPOINT WITH ACCUSTIM TECHNOLOGY