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

    INFRARED EXPOSURE HAND SWITCH

    K Number: K950442 · Decision Mar 31, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    30
    Applicant Total
    1
    Review Days
    63

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    Basic Information

    Device Name
    INFRARED EXPOSURE HAND SWITCH
    K Number
    K950442
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1980
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medical X-Ray Intl., Inc.
    Date Received
    January 27, 1995
    Decision Date
    March 31, 1995
    Product Code
    KXJ
    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
    KXJ Table, Radiologic

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