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

    MODEL 3471 CLINICAL REFRACTOMETER

    K Number: K941902 · Decision Dec 13, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    12
    Applicant Total
    6
    Review Days
    238

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    Basic Information

    Device Name
    MODEL 3471 CLINICAL REFRACTOMETER
    K Number
    K941902
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2800
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vee Gee Scientific, Inc.
    Date Received
    April 19, 1994
    Decision Date
    December 13, 1994
    Product Code
    JRE
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JRE Refractometer For Clinical Use

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    Other Clearances by Vee Gee Scientific, Inc.

    K Number Device Name
    K941903 MODEL 2740 CLINICAL REFRACTOMETER
    K941901 MODEL 2721 CLINICAL REFRACTOMETER
    K941906 MODEL 2730 CLINICAL REFRACTOMETER
    K941905 MODEL 3461 CLINICAL REFRACTOMETER
    K941904 MODEL A300CL CLINICAL REFRACTOMETER