BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    DALTON FOLDING WHEELCHAIRS

    K Number: K850178 · Decision Apr 25, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    129
    Registration Numbers
    129
    Same Product Code
    458
    Applicant Total
    5
    Review Days
    98

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    Basic Information

    Device Name
    DALTON FOLDING WHEELCHAIRS
    K Number
    K850178
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Dalton Instrument Corp.
    Date Received
    January 17, 1985
    Decision Date
    April 25, 1985
    Product Code
    IOR
    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
    IOR Wheelchair, Mechanical

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