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

    LUMISCOPE MODEL 2018 THERMOMETER

    K Number: K954792 · Decision Jun 21, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    13
    Review Days
    247

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    Basic Information

    Device Name
    LUMISCOPE MODEL 2018 THERMOMETER
    K Number
    K954792
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lumiscope Co., Inc.
    Date Received
    October 18, 1995
    Decision Date
    June 21, 1996
    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 Lumiscope Co., Inc.

    K Number Device Name
    K032714 CARDICARE MODEL MT-301F & MT-301C
    K931768 INTERFERENTIAL CURRENT THERAPY UNIT
    K925054 INFRARED LAMP
    K924081 LUMISONIC
    K920099 GYMMAN
    K901849 LUMISCOPE EMS 8000
    K901096 LUMISCOPE ALTERNATING PRESSURE PAD & PUMP
    K901726 LUMISCOPE MICRO 100
    K901809 LUMISCOPE ELECTRODES MODELS EL-08,11,15,06,21,25
    K894127 LUMISCOPE MODEL 1000/APCC MODEL 1000
    Search all 13 clearances from Lumiscope Co., Inc. →