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

    PCI CUSTOM DESIGN SERIES

    K Number: K861943 · Decision May 30, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    23
    Applicant Total
    1
    Review Days
    10

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    Basic Information

    Device Name
    PCI CUSTOM DESIGN SERIES
    K Number
    K861943
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3880
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Poston & Cole Intl.
    Date Received
    May 20, 1986
    Decision Date
    May 30, 1986
    Product Code
    IQC
    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
    IQC Wheelchair, Special Grade

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