BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    BCM-ARC 105 X-RAY MOBILE UNIT

    K Number: K890306 · Decision Apr 17, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    235
    Applicant Total
    8
    Review Days
    84

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    Basic Information

    Device Name
    BCM-ARC 105 X-RAY MOBILE UNIT
    K Number
    K890306
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1720
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    B C Medical , Ltd.
    Date Received
    January 23, 1989
    Decision Date
    April 17, 1989
    Product Code
    IZL
    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
    IZL System, X-Ray, Mobile

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