Search Filters

Search Results

Found 5 results

510(k) Data Aggregation

    K Number
    K062010
    Device Name
    RAPID DIGITAL THERMOMETER, MODEL RDT -18 SERIES
    Manufacturer
    GLOBAL TREASURE INDUSTRIES LTD.
    Date Cleared
    2006-10-27

    (102 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    GLOBAL TREASURE INDUSTRIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    It is an electronic thermometer used for clinical temperature measurement. It is intended for use at home and hospital environment for both children and adult.
    Device Description
    The Rapid Digital Thermometer is an electronic thermometer by using a thermistor as the temperature sensor. The thermometer uses a 1.5V button battery for operation.
    Ask a Question
    K Number
    K043033
    Device Name
    GLOBAL TREASURES FLUID FILLED TEETHER
    Manufacturer
    GLOBAL TREASURE INDUSTRIES LTD.
    Date Cleared
    2005-03-22

    (139 days)

    Product Code
    KKO
    Regulation Number
    872.5550
    Why did this record match?
    Applicant Name (Manufacturer) :

    GLOBAL TREASURE INDUSTRIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the fluid filled teether is to help to relieve the teething discomfort of teething. infants by providing a cool soothing effect. The Global Fluid Filled Teether is intended for over-the-counter use.
    Device Description
    Fluid Filled Teether
    Ask a Question
    K Number
    K030673
    Device Name
    FLEXIBLE TIP THERMOMETER, MODEL 011206
    Manufacturer
    GLOBAL TREASURE INDUSTRIES LTD.
    Date Cleared
    2003-04-04

    (31 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    GLOBAL TREASURE INDUSTRIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Flexible Tip Thermometer is an electronic thermometer to measure patient body temperature orally, rectally or axilliary (under arm). The Teddy Bear Flexible Tip Thermometer is intended for professional and over-the-counter use. A pediatric model will be available. The Flexible Tip Thermometer is an electronic thermometer to measure patient temperature. Targeted users include professional and over-the-counter users.
    Device Description
    Electronic Thermometer
    Ask a Question
    K Number
    K030658
    Device Name
    STANDARD THERMOMETER
    Manufacturer
    GLOBAL TREASURE INDUSTRIES LTD.
    Date Cleared
    2003-03-25

    (22 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    GLOBAL TREASURE INDUSTRIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Standard Thermometer is an electronic thermometer to measure patient body temperature orally, rectally or axilliary (under arm). The Teddy Bear Standard Thermometer is intended for professional and over-the-counter use. A pediatric model will be available. The plastic end of the thermometer has a molded Teddy Bear.
    Device Description
    Electronic Thermometer
    Ask a Question
    K Number
    K021052
    Device Name
    MODEL GT010706 ELECTRONIC THERMOMETER
    Manufacturer
    GLOBAL TREASURE INDUSTRIES LTD.
    Date Cleared
    2002-04-09

    (8 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    GLOBAL TREASURE INDUSTRIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indicated use- Measure of individual temperature Measurements- Oral, Axillary -under arm, Rectal Range of measurement- 90.0 degrees - 109.9 degrees F (32.0 degrees - 43 degrees C) Accuracy- +/-0.2 degrees F Targeted population- Individuals requiring temperature measurements Environment of use- Hospital and home Disposable / reusable- Reusable, clean with alcohol
    Device Description
    The intended product is an electronic digital thermometer for measuring patient temperature.
    Ask a Question

    Page 1 of 1