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

    OMRON DIGITAL FEVER THERMOMETER MODEL MC-3

    K Number: K881415 · Decision Oct 4, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    10
    Review Days
    183

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    Basic Information

    Device Name
    OMRON DIGITAL FEVER THERMOMETER MODEL MC-3
    K Number
    K881415
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Omron Electronics, Inc.
    Date Received
    April 4, 1988
    Decision Date
    October 4, 1988
    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 Omron Electronics, Inc.

    K Number Device Name
    K902255 OMRON PULSE STIMULATOR MODEL HV-F05
    K894563 OMRON DIGITAL BLOOD PRESSURE MONITOR MODEL HEM814F
    K893029 OMRON TRAVEL MASSAGER, MODEL HM-01
    K882393 DIGITAL BLOOD PRESSURE MONITOR MODEL HEM-703CP
    K881269 OMRON DIGITAL BLOOD PRESSURE MONITOR HEM-701C
    K872527 OMRON DIGITAL FEVER THERMOMETER MODEL MC-12B
    K871888 DIGITAL FEVER THERMOMETER MODEL MC-5
    K871207 OMRON DIGITAL BLOOD PRESSURE MONITOR HEM-401C
    K870956 OMRON DIGITAL FEVER THERMOMETER MODEL MC-7