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Found 8 results
510(k) Data Aggregation
K Number
K111637Device Name
INFRARED EAR THERMOMETER
Manufacturer
RADIANT INNOVATION, INC.
Date Cleared
2011-12-06
(176 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
RADIANT INNOVATION, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting.
Device Description
The Radiant Innovation Inc., Infrared Ear Thermometer, Models THP series are electronic thermometers that use an infrared detector (thermopile detector) to detect body temperature using infrared radiation from the auditory canal. Its operation is based on measuring the natural infrared thermal radiation emanating from the tympanic membrane and the adjacent surfaces of the patient. To measure ear temperature, the ear thermometer is inserted into a patient's outer ear canal. A start button is pressed to start the measurement through the radiation exchanges. The electrical signal read out from the detector is amplified by hardware and processed by the microprocessor. The temperature from the auditory canal in the neonatal, pediatric and adult population used for intermittent monitoring of human body temperature in the home setting.
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K Number
K103097Device Name
INFRARED EAR THERMOMETER
Manufacturer
RADIANT INNOVATION, INC.
Date Cleared
2010-12-29
(70 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
RADIANT INNOVATION, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used for intermittent monitoring of human body temperature in the home setting.
Device Description
The Radiant Innovation Inc., Infrared Ear Thermometer, Models THK09, IRT 3020 are electronic thermometers that use an infrared detector (thermopile detector) to detect body temperature using infrared radiantion from the auditory canal. Its operation is based on measuring the natural infrared thermal radiation emanating from the tympanic membrane and the adjacent surfaces of the patient.
To measure ear temperature, the ear thermometer is inserted into a patient's outer ear canal. A start button is pressed to start the measurement through the radiation exchanges. The electrical signal read out from the detector is amplified by hardware and processed by the microprocessor. The temperature from the auditory canal in the neonatal, pediatric and adult population used for intermittent monitoring of human body temperature in the home setting.
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K Number
K102187Device Name
RII INFRARED EAR THERMOMETER,
Manufacturer
RADIANT INNOVATION, INC.
Date Cleared
2010-12-10
(129 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
RADIANT INNOVATION, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting.
Device Description
The Radiant Innovation Inc., Infrared Ear Thermometer, Model TH709L(E) is electronic thermometer using an infrared detector (thermopile detector) to detect body temperature from the auditory canal. Its operation is based on measuring the natural thermal radiation emanating from the tympanic membrane and the adjacent surfaces of the patient.
To measure ear temperature, the ear thermometer is inserted into a patient's outer ear canal. A start button is pressed to start the measurement through the radiation exchanges. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The measured temperature then appears on a LCD display. The total operation takes a few seconds.
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K Number
K063185Device Name
RII INFRARED EAR THERMOMETER, MODELS TH5XY SERIES
Manufacturer
RADIANT INNOVATION, INC.
Date Cleared
2006-11-17
(28 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
RADIANT INNOVATION, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting.
Device Description
The Radiant Innovation Inc., Infrared Ear Thermometer, Models TH5XY series are electronic thermometers using an infrared detector (thermopile detector) to detect body temperature from the auditory canal. Its operation is based on measuring the natural thermal radiation emanating from the tympanic membrane and the adjacent surfaces of the patient. To measure ear temperature, the ear thermometer is inserted into a patient's outer ear canal. A start button is pressed to start the measurement through the radiation exchanges. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The measured temperature then appears on a 1.CD display. The total operation takes a few sconds.
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K Number
K040377Device Name
RII INFRARED EAR THERMOMETER, MODELS THXXN SERIES
Manufacturer
RADIANT INNOVATION, INC.
Date Cleared
2004-09-16
(212 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
RADIANT INNOVATION, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting.
Device Description
The Radiant Innovation Inc., Infrared Ear Thermometer, Models THxxN series are electronic thermometers using an infrared detector (thermopile detector) to detect body temperature from the auditory canal. Its operation is based on measuring the natural thermal radiation emanating from the tympanic membrane and the adjacent surfaces of the patient.
To measure ear temperature, the ear thermometer is inserted into a patient's outer ear canal. A start button is pressed to start the measurement through the radiation exchanges. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The measured temperature then appears on a LCD display. The total operation takes a few seconds.
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K Number
K030324Device Name
RADIANT INNOVATION INC. INFRARED EAR THERMOMETER, MODELS TH1 SERIES
Manufacturer
RADIANT INNOVATION, INC.
Date Cleared
2003-02-27
(27 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
RADIANT INNOVATION, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting.
Device Description
The Radiant Innovation Inc., Infrared Ear Thermometer, Models TH1 series are electronic thermometers using an infrared detector (thermopile detector) to detect body temperature from the auditory canal. Its operation is based on measuring the natural thermal radiation emanating from the tympanic membrane and the adjacent surfaces of the patient.
To measure ear temperature, the ear thermometer is inserted into a patient's outer ear canal. A start button is pressed to start the measurement through the radiation exchanges. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The measured temperature then appears on a LCD display. The total operation takes a few seconds.
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K Number
K020504Device Name
INFRARED EAR THERMOMETER, MODELS TH88 SERIES
Manufacturer
RADIANT INNOVATION, INC.
Date Cleared
2002-02-28
(13 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
RADIANT INNOVATION, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting.
Device Description
The Radiant Innovation Inc., Infrared Ear Thermometer, Models TH88 series are electronic thermometers using an infrared detector (thermopile detector) to detect body temperature from the auditory canal. Its operation is based on measuring the natural thermal radiation emanating from the tympanic membrane and the adjacent surfaces of the patient. To measure ear temperature, the ear thermometer is inserted into a patient's outer ear canal. A start button is pressed to start the measurement through the radiation exchanges. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The total operation takes a few seconds. The measured temperature then appears on a LCD display.
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K Number
K011059Device Name
INFARED EAR THERMOMETER, MODEL TH8 SERIES
Manufacturer
RADIANT INNOVATION, INC.
Date Cleared
2001-09-17
(164 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
RADIANT INNOVATION, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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