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

    ERBIUM X-RAY FILTER

    K Number: K860760 · Decision Jun 10, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    54
    Same Product Code
    39
    Applicant Total
    1
    Review Days
    102

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    Basic Information

    Device Name
    ERBIUM X-RAY FILTER
    K Number
    K860760
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1760
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Reactor Experiments, Inc.
    Date Received
    February 28, 1986
    Decision Date
    June 10, 1986
    Product Code
    ITY
    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
    ITY Assembly, Tube Housing, X-Ray, Diagnostic

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