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

    SEJOY, MODEL MT-403

    K Number: K051699 · Decision Feb 6, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    14
    Review Days
    227

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    Basic Information

    Device Name
    SEJOY, MODEL MT-403
    K Number
    K051699
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sejoy Electronics & Instruments Co., Ltd.
    Date Received
    June 24, 2005
    Decision Date
    February 6, 2006
    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 Sejoy Electronics & Instruments Co., Ltd.

    K Number Device Name
    K161577 Arm-Type Fully Automatic Digital Blood Pressure Monitor
    K153149 Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132, MT-4333, MT-4326, MT-4726, MT-4335, MT-4735, MT-09, MT-30, MT-31, MT-36
    K153146 Infrared Ear Thermometer
    K152426 Wrist - Type Fully Automatic Digital Blood Pressure Monitor
    K152687 Arm-Type Fully Automatic Digital Blood Pressure Monitor
    K150545 Arm-Type Fully Automatic Digital Blood Pressure Monitor (BP-1305, BP-1307, BP-1326, BP-1318, BP-1319, BP-1211, BP-1312, BSP-11, BSP-12, BSP-13)
    K141755 ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
    K120554 ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
    K121355 WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
    K110776 DIGITAL THERMOMETER MT SERIES
    Search all 14 clearances from Sejoy Electronics & Instruments Co., Ltd. →