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

    Comfort Cover

    K Number: K161920 · Decision Jul 15, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    175
    Applicant Total
    1
    Review Days
    2

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    Basic Information

    Device Name
    Comfort Cover
    K Number
    K161920
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1710
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Precision Dynamics Corporation
    Date Received
    July 13, 2016
    Decision Date
    July 15, 2016
    Product Code
    IZH
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IZH System, X-Ray, Mammographic

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