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

    PHILIPS EASY DIAGNOST

    K Number: K970640 · Decision Mar 21, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    76
    Applicant Total
    71
    Review Days
    29

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    Basic Information

    Device Name
    PHILIPS EASY DIAGNOST
    K Number
    K970640
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1980
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Philips Medical Systems North America, Inc.
    Date Received
    February 20, 1997
    Decision Date
    March 21, 1997
    Product Code
    IXR
    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
    IXR Table, Radiographic, Tilting

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