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

    GUARDIAN AND ANDINO MODELS

    K Number: K932991 · Decision Jan 28, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    32
    Applicant Total
    1
    Review Days
    224

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    Basic Information

    Device Name
    GUARDIAN AND ANDINO MODELS
    K Number
    K932991
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2920
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Coltemp, Inc.
    Date Received
    June 18, 1993
    Decision Date
    January 28, 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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