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510(k) Data Aggregation
K Number
K021028Device Name
MODEL GT980201 ELECTRONIC THERMOMETER
Manufacturer
Date Cleared
2002-04-08
(10 days)
Product Code
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
GLOBAL TREASURE LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Indicated use- Measure of individual temperature
Measurements- Oral, Axillary -under arm, Rectal
Range of measurement- 90.0° - 108.0° F (32.0° - 42.0° C)
Accuracy- +/-0.2° 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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K Number
K001279Device Name
GT990402 DIGITAL THERMOMETER
Manufacturer
Date Cleared
2000-04-28
(7 days)
Product Code
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
GLOBAL TREASURE LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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