BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    AMG MED BRAND CLINICAL GLASS THERMOMETER

    K Number: K940394 · Decision May 4, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    32
    Applicant Total
    1
    Review Days
    98

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    Basic Information

    Device Name
    AMG MED BRAND CLINICAL GLASS THERMOMETER
    K Number
    K940394
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2920
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Technolab Industries (Canada) , Ltd.
    Date Received
    January 26, 1994
    Decision Date
    May 4, 1994
    Product Code
    FLK
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FLK Thermometer, Clinical Mercury

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