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

    PATHFINDER MOBILE C ARM

    K Number: K981131 · Decision Jun 26, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    68
    Same Product Code
    81
    Applicant Total
    13
    Review Days
    88

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    Basic Information

    Device Name
    PATHFINDER MOBILE C ARM
    K Number
    K981131
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    892.1650
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Acoma Medical Imaging, Inc.
    Date Received
    March 30, 1998
    Decision Date
    June 26, 1998
    Product Code
    OXO
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OXO Image-Intensified Fluoroscopic X-Ray System, Mobile

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