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

    MULTI CAMERA CONTROL UNIT (MCCU)

    K Number: K884028 · Decision Mar 15, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    299
    Applicant Total
    1
    Review Days
    173

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    Basic Information

    Device Name
    MULTI CAMERA CONTROL UNIT (MCCU)
    K Number
    K884028
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1650
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Leybold-Inficon, Inc.
    Date Received
    September 23, 1988
    Decision Date
    March 15, 1989
    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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