BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    EZ-SCOPE AN & EZ-SCOPE AN LITE

    K Number: K020643 · Decision May 28, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    129
    Applicant Total
    1
    Review Days
    90

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    Basic Information

    Device Name
    EZ-SCOPE AN & EZ-SCOPE AN LITE
    K Number
    K020643
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1100
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Health Policy Resorters Group, LLC
    Date Received
    February 27, 2002
    Decision Date
    May 28, 2002
    Product Code
    IYX
    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
    IYX Camera, Scintillation (Gamma)

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