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510(k) Data Aggregation
K Number
K062010Device 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
880.2910Why 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.
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K Number
K043033Device Name
GLOBAL TREASURES FLUID FILLED TEETHER
Manufacturer
GLOBAL TREASURE INDUSTRIES LTD.
Date Cleared
2005-03-22
(139 days)
Product Code
KKO
Regulation Number
872.5550Why 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
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K Number
K030673Device Name
FLEXIBLE TIP THERMOMETER, MODEL 011206
Manufacturer
GLOBAL TREASURE INDUSTRIES LTD.
Date Cleared
2003-04-04
(31 days)
Product Code
FLL
Regulation Number
880.2910Why 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
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K Number
K030658Device Name
STANDARD THERMOMETER
Manufacturer
GLOBAL TREASURE INDUSTRIES LTD.
Date Cleared
2003-03-25
(22 days)
Product Code
FLL
Regulation Number
880.2910Why 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
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K Number
K021052Device Name
MODEL GT010706 ELECTRONIC THERMOMETER
Manufacturer
GLOBAL TREASURE INDUSTRIES LTD.
Date Cleared
2002-04-09
(8 days)
Product Code
FLL
Regulation Number
880.2910Why 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.
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