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

    CLK INT'L. SANITARY LATEX PROBE COVER, CLK ULTRASOUND PROBE COVER

    K Number: K974301 · Decision Feb 6, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    398
    Registration Numbers
    399
    Same Product Code
    408
    Applicant Total
    2
    Review Days
    81

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    Basic Information

    Device Name
    CLK INT'L. SANITARY LATEX PROBE COVER, CLK ULTRASOUND PROBE COVER
    K Number
    K974301
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1570
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Clk Intl., Inc.
    Date Received
    November 17, 1997
    Decision Date
    February 6, 1998
    Product Code
    ITX
    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
    ITX Transducer, Ultrasonic, Diagnostic

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    Other Clearances by Clk Intl., Inc.

    K Number Device Name
    K974371 CLK INT'L POWDER FREE LATEX EXAMINATION GLOVE