BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇩🇰 Denmark

    Orion

    K Number: K200529 · Decision Aug 12, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    21
    Applicant Total
    17
    Review Days
    163

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    Basic Information

    Device Name
    Orion
    K Number
    K200529
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Interacoustics A/S
    Date Received
    March 2, 2020
    Decision Date
    August 12, 2020
    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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