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

    VERTIGONE BPPV GOGGLE

    K Number: K082634 · Decision Apr 7, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    21
    Applicant Total
    1
    Review Days
    209

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    Basic Information

    Device Name
    VERTIGONE BPPV GOGGLE
    K Number
    K082634
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vertigone, Inc.
    Date Received
    September 10, 2008
    Decision Date
    April 7, 2009
    Product Code
    LXV
    Advisory Committee
    Unknown
    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
    LXV Apparatus, Vestibular Analysis

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