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

    PEE WEE THERMOMETERS

    K Number: K853515 · Decision Oct 16, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    13
    Applicant Total
    2
    Review Days
    55

    Basic Information

    Device Name
    PEE WEE THERMOMETERS
    K Number
    K853515
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.2900
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    JOEL R.L. EHREN KRANZ
    Date Received
    August 22, 1985
    Decision Date
    October 16, 1985
    Product Code
    FQZ
    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
    FQZ Thermometer, Clinical Color Change

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