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

    G.E. FLUOROCON 300 IMAGING SYSTEM

    K Number: K902981 · Decision Nov 7, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    299
    Applicant Total
    11
    Review Days
    134

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    Basic Information

    Device Name
    G.E. FLUOROCON 300 IMAGING SYSTEM
    K Number
    K902981
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1650
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Electromek Diagnostic Systems, Inc.
    Date Received
    June 26, 1990
    Decision Date
    November 7, 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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    K902984 G.E. AMX 110, AMX II AND AMX 3 X-RAY UNITS
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    Search all 11 clearances from Electromek Diagnostic Systems, Inc. →