BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    CORONET 100

    K Number: K913785 · Decision Dec 31, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    75
    Applicant Total
    5
    Review Days
    130

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    Basic Information

    Device Name
    CORONET 100
    K Number
    K913785
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1900
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Micro-Shev , Ltd.
    Date Received
    August 23, 1991
    Decision Date
    December 31, 1991
    Product Code
    GWJ
    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
    GWJ Stimulator, Auditory, Evoked Response

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