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

    OMEGA TRAC, MODEL Z100

    K Number: K993160 · Decision Nov 18, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    580
    Applicant Total
    8
    Review Days
    58

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    Basic Information

    Device Name
    OMEGA TRAC, MODEL Z100
    K Number
    K993160
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    890.3860
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Teftec Corp.
    Date Received
    September 21, 1999
    Decision Date
    November 18, 1999
    Product Code
    ITI
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ITI Wheelchair, Powered

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