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

    RADX VENT-AL MECHANICAL RESPORATOR

    K Number: K800751 · Decision May 8, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    25
    Applicant Total
    1
    Review Days
    34

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    Basic Information

    Device Name
    RADX VENT-AL MECHANICAL RESPORATOR
    K Number
    K800751
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1860
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Radx Corp.
    Date Received
    April 4, 1980
    Decision Date
    May 8, 1980
    Product Code
    KPX
    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
    KPX Changer, Radiographic Film/Cassette

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