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

    PATIENT DATA MANAGEMENT SYSTEM (PROJECT 735)

    K Number: K894230 · Decision Aug 28, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    733
    Applicant Total
    13
    Review Days
    70

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    Basic Information

    Device Name
    PATIENT DATA MANAGEMENT SYSTEM (PROJECT 735)
    K Number
    K894230
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Siemens Medical Laboratories, Inc.
    Date Received
    June 19, 1989
    Decision Date
    August 28, 1989
    Product Code
    IYE
    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
    IYE Accelerator, Linear, Medical

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