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

    TELE-TEMP THERMOMETER

    K Number: K890202 · Decision Apr 5, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    9
    Review Days
    78

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    Basic Information

    Device Name
    TELE-TEMP THERMOMETER
    K Number
    K890202
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Rocky Mountain Medical Corp.
    Date Received
    January 17, 1989
    Decision Date
    April 5, 1989
    Product Code
    FLL
    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
    FLL Continuous Measurement Thermometer

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    Other Clearances by Rocky Mountain Medical Corp.

    K Number Device Name
    K860120 NURSERY AMBIENT LIGHT METER
    K852167 ISOVOL-EXCHANGE TRAY
    K853970 ALPHA CHUCK
    K853790 BABE SHADE-INFANT AMBIENT LIGHT INTENSITY REDUCER
    K851876 PREFER INCONTINENCE AID
    K834430 OMNI INFANT PHOTOTHERAPY UNIT
    K832298 BABY LIGHT DOSIMETER
    K837494 BABY LIGHT METER