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

    PEM 2400 PET SCANNER

    K Number: K032063 · Decision Aug 18, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    470
    Applicant Total
    2
    Review Days
    46

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    Basic Information

    Device Name
    PEM 2400 PET SCANNER
    K Number
    K032063
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1200
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pem Technologies
    Date Received
    July 3, 2003
    Decision Date
    August 18, 2003
    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 Pem Technologies

    K Number Device Name
    K003775 PORTABLE BREAST COMPRESSION DEVICE