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

    CMS RECORD AND VERIFY SYSTEM

    K Number: K882484 · Decision Dec 21, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    52
    Applicant Total
    23
    Review Days
    189

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    Basic Information

    Device Name
    CMS RECORD AND VERIFY SYSTEM
    K Number
    K882484
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5900
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Computerized Medical Systems, Inc.
    Date Received
    June 15, 1988
    Decision Date
    December 21, 1988
    Product Code
    JAD
    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
    JAD System, Therapeutic, X-Ray

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