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

    gammaCore-S

    K Number: K173442 · Decision Jan 23, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    8
    Applicant Total
    4
    Review Days
    78

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    Basic Information

    Device Name
    gammaCore-S
    K Number
    K173442
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5892
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Electrocore, LLC
    Date Received
    November 6, 2017
    Decision Date
    January 23, 2018
    Product Code
    PKR
    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
    PKR Non-Invasive Vagus Nerve Stimulator - Headache

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    Other Clearances by Electrocore, LLC

    K Number Device Name
    K180538 gammaCore Sapphire
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    DEN150048 gammaCore Non-invasive Vagus Nerve Stimulator