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

    MODEL B-200 C-ARM & MODEL C-300 CARDIAC TABLE

    K Number: K902005 · Decision Sep 20, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    299
    Applicant Total
    8
    Review Days
    139

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    Basic Information

    Device Name
    MODEL B-200 C-ARM & MODEL C-300 CARDIAC TABLE
    K Number
    K902005
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1650
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Omega Medical Imaging, Inc.
    Date Received
    May 4, 1990
    Decision Date
    September 20, 1990
    Product Code
    JAA
    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
    JAA System, X-Ray, Fluoroscopic, Image-Intensified

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