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

    Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large

    K Number: K212355 · Decision Aug 26, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    96
    Applicant Total
    1
    Review Days
    28

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    Basic Information

    Device Name
    Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large
    K Number
    K212355
    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
    Checkpoint Surgical
    Date Received
    July 29, 2021
    Decision Date
    August 26, 2021
    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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