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510(k) Data Aggregation
K Number
K042202Device Name
TEMPTELLER - HIGH SPEED DIGITAL THERMOMETERS, MODELS DT-302, DT-312, DT-412, DT-502
Manufacturer
Date Cleared
2004-09-10
(28 days)
Product Code
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
ORIENTAL SYSTEM TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device is an electronic clinical thermometer using a thermistor to detect body temperature from the oral , armpit , and rectal in neonatal , pediatric and adult population used in the clinical and home testing .
Device Description
The OSTI Temp-Teller High Speed Digital Thermometer(Model DT-302 DT-312 , DT-412 , DT-502) is an electronic thermometer using a thermistor as the temperature sensor . The sensor's electric signal is calculated and displayed by an ASIC (Application Specific IC)
The High Speed digital thermometer comprises: a thermistor for temperature sensing , a reference resistor for comparing the resistance of the thermistor , a buzzer for sounding effect , an ASIC and a LCD display for calculating and displaying the target temperature digitally . The system uses a 1.55 V battery for the power supply and the battery power is automatically check by the ASIC and displayed in LCD if the battery is exhausted .
The OSTI Temp-Teller High Speed Digital Thermometer (Model DT-302 , DT-312 . DT-412 . DT-502) can makes temperature taking faster , its temperature stabilize reading within 10 sec in a 37℃ water bath at ambient temperature 23+1-2°C .
DT-312 ,DT-412 is high speed digital thermometers, with flexible front tip and with power /measuring button set aside with LCD display and with water resistant function .
DT502 is high speed digital thermometers, with rigid front tip and with power /measuring button set aside with LCD display and with water resistant function .
DT302 is high speed digital thermometers, with rigid front tip and with power /measuring button on top end and with water resistant function .
The DT-302 , DT-312 , DT-412 , DT-502 is identical in functionality and performance .
The essential change include 1)Metal cap / Thermistor mechanical structure change to improve thermal transmission 2)Firm ware 3)Material 4)Shape layout and dimension .
The fundamental scientific technology of the modified device remains the same as that of the 510(k) cleared device.
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K Number
K030299Device Name
TEMPTELLER INFARED EAR THERMOMETERS, MODEL CT-31/31DX/32/32DX
Manufacturer
Date Cleared
2003-02-25
(27 days)
Product Code
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
ORIENTAL SYSTEM TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device is an electronic clinical thermometer using an infrared sensor to detect the human body temperature from the auditory canal in the neonatal, pediatric and adult Populations used in the home setting.
Device Description
The OSTI TempTeller® Infrared Ear Thermometers, model CT-31/31DX/32/32DX, is an electronic thermometer using an infrared sensor to detect human body temperature from the auditory canal. Its operation is based on measuring the natural thermal radiation emanating from the tympanic membrane (eardrum) and the adjacent tissue. OSTI TempTeller® Infrared Ear Thermometers, model CT-31/31DX/32/32DX, consists mainly of five parts: an IR sensor packed together with an ambient temperature sensor, a waveguide, a heat sink made of zinc alloy, a LCD display and the associated circuit. The tympanic membrane (eardrum) is thin and flooded with blood at the core temperature. The wavequide, usually a cylindrical pipe with a highly reflective inner surface for confining the radiation, is adaptive to the outer without contacting the eardrum. When inserting the probe into the ear canal, the radiation fluxes transfer among the tympanum membrane (eardrum), the IR sensor, and the inner surface of the wavequide. The ambient sensor is packed with the IR sensor to monitor the ambient temperature of the IR sensor. To measure core temperature, an ear thermometer is inserted into a patient's outer ear canal. An activation button is pressed to start the measurement through the radiation exchanges. The electrical signal readouts form the IR sensor and the ambient temperature sensor are fed to the circuit for amplification, digitization and calculation. The measured temperature then appears on the LCD. The total operation takes one second. The CT-31/31DX/32/32DX is identical in functionality and performance with the essential change being the external shape of the devices. The modifications to our original 510(k) cleared device, model CT-30/30DX, include dimensional and firmware. The fundamental scientific technology of the modified device remains the same as that of the 510(k) cleared device.
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K Number
K010235Device Name
TEMPTELLER INFRARED EAR THERMOMETER, MODEL CT-30/ CT-30DX
Manufacturer
Date Cleared
2001-07-09
(165 days)
Product Code
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
ORIENTAL SYSTEM TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K001008Device Name
TEMPTELLER INFRARED EAR THERMOMETER, MODELS TT-901, TT-911 AND TT-921
Manufacturer
Date Cleared
2000-04-12
(14 days)
Product Code
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
ORIENTAL SYSTEM TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K992601Device Name
TEMP TELLER - DIGITAL THERMOMETER, MODELS DT-101, DT-102, DT-103, DT-201, DT-202, DT-203
Manufacturer
Date Cleared
1999-10-27
(85 days)
Product Code
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
ORIENTAL SYSTEM TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device is an electronic clinical thermometer using a thermistor to detect body temperature from the oral, ampit, and rectal in the neonatal, pediatric and adult population used in the clinical and home testing.
Device Description
The OSTI Temp - Teller Digital Thermometer, (Models DT-101, DT-102, DT-103, DT-201, DT-202, and DT-203). is an electronic thermometer using a thermistor as the temperature sensor. The sensor's electric signal is then calculated and displayed by an ASIC (Application Specific IC) Models DT-101 and DT-201 display the temperature within a 100" of a degree. Models DT-101, DT-102 and DT-103 employ a 1.5 times larger LCD display than competitive products for easier reading. Models DT-101, DT-102, DT-201 and DT-202 have a water-resistant function. The digital thermometer comprises: a thermistor for temperature sensing, a reference resistor for comparing the resistance of the thermistor, a buzzer for sounding effect, an ASIC and a LCD display for calculating and displaying the target temperature digitally which the thermistor is immersed. The system uses a 1.5V DC battery for the power supply and the battery power is displayed in LCD if the battery is exhausted.
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K Number
K984497Device Name
TEMP TELLER-INFRARED TYMPANIC THERMOMETER, MODELS TT-200, TT-201
Manufacturer
Date Cleared
1999-05-26
(160 days)
Product Code
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
ORIENTAL SYSTEM TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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 OSTI Temp - Teller Infrared Tympanic Thermometer, Models TT-200, TT-201, is an electronic thermometer using an infrared sensor (pyroelectric heat sensor, employing the principle of the electrically calibrated pyroelectric radiometer (ECPR)) 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.
OSTI Temp -Teller Infrared Tympanic Thermometer, Model TT-201, consists mainly of five parts: an IR sensor, a barrel, a shutter, an ambient temperature sensor, and the associated circuit.
The ear canal guides sound to the eardrum, which is thin and flooded with blood at the core temperature. The barrel, usually a cylindrical pipe with a highly reflective inner surface for confining the radiation, is adaptive to the outer canal without contracting the eardrum. The shutter controls when the flux is transferred to the IR sensor. When the shutter is open, radiative fluxes transfer among the tympanum, the IR sensor, and the inner surface of the barrel. The ambient sensor is mounted near the IR sensor to monitor the ambient temperature.
To measure core temperature, a tympanic thermometer is inserted into a patient's outer ear canal. A start button is pressed to open the shutter momentarily and 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 display. The total operation takes a few seconds.
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