BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    VJW2919 PNEUMATIC COMPRESSION UPGRADE

    K Number: K920938 · Decision Jun 17, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    175
    Applicant Total
    7
    Review Days
    111

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    Basic Information

    Device Name
    VJW2919 PNEUMATIC COMPRESSION UPGRADE
    K Number
    K920938
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1710
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Varian Canada, Inc.
    Date Received
    February 27, 1992
    Decision Date
    June 17, 1992
    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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