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

    SYSTEM 2000, ROTATIONAL VESTIBULAR CHAIR

    K Number: K922037 · Decision Oct 26, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    21
    Applicant Total
    5
    Review Days
    178

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    Basic Information

    Device Name
    SYSTEM 2000, ROTATIONAL VESTIBULAR CHAIR
    K Number
    K922037
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Micromedical Technologies, Inc.
    Date Received
    May 1, 1992
    Decision Date
    October 26, 1992
    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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