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

    POSICAM SYSTEM MODEL 6.5 POSICAM-HZ SYSTEM

    K Number: K911275 · Decision May 9, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    470
    Applicant Total
    4
    Review Days
    48

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    Basic Information

    Device Name
    POSICAM SYSTEM MODEL 6.5 POSICAM-HZ SYSTEM
    K Number
    K911275
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1200
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Positron
    Date Received
    March 22, 1991
    Decision Date
    May 9, 1991
    Product Code
    KPS
    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
    KPS System, Tomography, Computed, Emission

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    Other Clearances by Positron

    K Number Device Name
    K926206 POSICAM-HZ & POSICAM-HZL
    K894998 MODIFIED POSICAM SYSTEM MODEL 6.5
    K810537 AUTOMATIC SCREENING AUDIOMETER