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

    RMI RESPIRATORY GATING SYSTEM MODEL 301

    K Number: K854976 · Decision May 7, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    3
    Applicant Total
    12
    Review Days
    146

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    Basic Information

    Device Name
    RMI RESPIRATORY GATING SYSTEM MODEL 301
    K Number
    K854976
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1970
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Radiation Measurements, Inc.
    Date Received
    December 12, 1985
    Decision Date
    May 7, 1986
    Product Code
    IXO
    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
    IXO Synchronizer, Ecg / Respirator, Radiographic

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