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Found 3 results
510(k) Data Aggregation
K Number
K033077Device Name
EASYTEM DUO, FOREHEAD/EAR THERMOMETER, MODEL BT-021
Manufacturer
Date Cleared
2004-04-30
(214 days)
Product Code
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
METATECH CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal or on the forehead in the neonatal, pediatric and adult population used at home.
Device Description
The easytem duo Forehead/Ear Thermometer is a dual purpose hand held instrument that measures body temperature on the forehead or through the opening of the auditory canal. The forehead operation is based on measuring the temperature on the surface of the forehead while the ear operation measures the natural thermal radiation emitted from the tympanic membrane and adjacent surfaces.
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K Number
K033082Device Name
9 SECOND DIGITAL THERMOMETER, MODEL BT-S09
Manufacturer
Date Cleared
2003-12-03
(65 days)
Product Code
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
METATECH CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This device is an electronic clinical thermometer using a themistor probe sensor to detect oral, rectal or axillary temperatures. It is intended for home use on people of all ages.
Device Description
The 9 second Digital Thermometer is designed to measure body temperature. The device is measuring oral, rectal or axillary temperatures by change of resistance in a thermistor located in the tip of the device. When the probe, particular the metal tip is in contact with the body, the thermistor in the probe will generate equivalent electrical resistance, which will be processed by a micro computer chip in the circuitry and then displayed.
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K Number
K020520Device Name
EASYTEM EAR THERMOMETER, MODEL BT-020
Manufacturer
Date Cleared
2002-08-06
(168 days)
Product Code
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
METATECH CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This device is an electronic clinical thermometer using an infrared sensor to detect body temperature via the auditory canal in the neonatal, pediatric and adult population used at home.
Device Description
The easytem Ear Thermometer is a hand held instrument that measures body temperature through the opening of the auditory canal. Operation is based on measuring the natural thermal radiation emitted from the tympanic membrane and adjacent surfaces.
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