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

    MODEL DX MICRO COMPUTER CONTROL

    K Number: K970094 · Decision May 12, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    550
    Applicant Total
    2
    Review Days
    122

    Basic Information

    Device Name
    MODEL DX MICRO COMPUTER CONTROL
    K Number
    K970094
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3860
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    INVACARE RESPIRATORY CORP.
    Date Received
    January 10, 1997
    Decision Date
    May 12, 1997
    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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