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

    TEMPTREND PEDS AXILLARY TEMP. INDICATOR

    K Number: K841913 · Decision Nov 2, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    20
    Applicant Total
    2
    Review Days
    177

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    Basic Information

    Device Name
    TEMPTREND PEDS AXILLARY TEMP. INDICATOR
    K Number
    K841913
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Biosynergy, Inc.
    Date Received
    May 9, 1984
    Decision Date
    November 2, 1984
    Product Code
    KPD
    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
    KPD Strip, Temperature, Forehead, Liquid Crystal

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    Other Clearances by Biosynergy, Inc.

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