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

    MEDISYS RECORD AND VERIFY SYSTEM

    K Number: K893978 · Decision Sep 1, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    733
    Applicant Total
    1
    Review Days
    91

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    Basic Information

    Device Name
    MEDISYS RECORD AND VERIFY SYSTEM
    K Number
    K893978
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Medisys, Inc.
    Date Received
    June 2, 1989
    Decision Date
    September 1, 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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