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

    BENNETT MAMMOGRAPHY POSITIONING CHAIR MODEL NO. M-PCH

    K Number: K940701 · Decision Apr 28, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    175
    Applicant Total
    23
    Review Days
    71

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    Basic Information

    Device Name
    BENNETT MAMMOGRAPHY POSITIONING CHAIR MODEL NO. M-PCH
    K Number
    K940701
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1710
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bennett X-Ray Corp.
    Date Received
    February 16, 1994
    Decision Date
    April 28, 1994
    Product Code
    IZH
    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
    IZH System, X-Ray, Mammographic

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