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

    ISOTECHNOLOGIES LIFTSTATION & LIFTWORKS SOFTWARE

    K Number: K912175 · Decision Jun 7, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    11
    Applicant Total
    6
    Review Days
    22

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    Basic Information

    Device Name
    ISOTECHNOLOGIES LIFTSTATION & LIFTWORKS SOFTWARE
    K Number
    K912175
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3690
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Isotechnologies, Inc.
    Date Received
    May 16, 1991
    Decision Date
    June 7, 1991
    Product Code
    INK
    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
    INK Stretcher, Wheeled, Powered

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