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

    P-7 COMPUTED TOMOGRAPHY SYSTEM

    K Number: K882378 · Decision Oct 11, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    818
    Applicant Total
    190
    Review Days
    125

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    Basic Information

    Device Name
    P-7 COMPUTED TOMOGRAPHY SYSTEM
    K Number
    K882378
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1750
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Philips Medical Systems (Cleveland), Inc.
    Date Received
    June 8, 1988
    Decision Date
    October 11, 1988
    Product Code
    JAK
    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
    JAK System, X-Ray, Tomography, Computed

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