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510(k) Data Aggregation
K Number
K080981Device Name
EAR THERMOMETER, MODELS ST66 AND ST67
Manufacturer
MESURE TECHNOLOGY CO.,LTD.
Date Cleared
2008-05-02
(25 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
MESURE TECHNOLOGY CO.,LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device measures the body temperature from the auditory canal of of a patient by means of an infrared sensor coupled with an electronic signal amplification, conditioning and digital LCD (display) unit. The device is reusable and intended for home use on people of all ages.
Device Description
The Mesure ear thermometer, models ST66, and ST67, are the handheld electronic thermometers that measures the temperature through the opening of the auditory canal by using a thermopile as the temperature sensor. The signal of sensor is calculated and displayed by an ASIC (Application Specific IC) - controlled circuit, which is considered the hard-wire control instead of programmable control. From the construction point of view, the ear thermometer comprises of a thermopile for the measuring sensor, a reference thermistor for comparison of temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermopile sensor detect the ear canal temperature through the infrared. This system uses a 3.0 V DC battery for operation of complete system whenever the battery is low, the ASIC circuit will detect the low battery condition automatically, and displays 'Low battery' in LCD display. Regarding the performance of ST66 and ST67, they were designed and verified according to the US standard ASTM E 1965-00.
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K Number
K071019Device Name
DIGITAL CLINICAL THERMOMETER/MODELS ST8C SERIES
Manufacturer
MESURE TECHNOLOGY CO.,LTD.
Date Cleared
2007-04-27
(17 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
MESURE TECHNOLOGY CO.,LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device measures the body temperature of a patient by means of a sensor (transducer) coupled with electronic signal amplification, conditioning and digital LCD (display) unit. The device is reusable and intended for oral, axillary or rectal temperature measurements.
Device Description
Digital Clinical Thermometer, Models ST8C Series
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K Number
K063542Device Name
WIRELESS TEMPERATURE MONITOR / MODELS ST323C AND ST323F.
Manufacturer
MESURE TECHNOLOGY CO.,LTD.
Date Cleared
2007-04-10
(137 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
MESURE TECHNOLOGY CO.,LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The wireless temperature monitor, model ST323C, ST323F are the battery-operated electronic devices with intended use of measuring human body temperature precisely. This device is reusable and intended for armpit temperature measurement of the person of all age.
Device Description
The ST323C and ST323F are the wireless temperature monitor intended to be worn at left arm to monitor the armpit temperature continuously. ST323C and ST323F is composed of two operational parts, the receiver and transmitter. The receiver is the main operation unit on which, the LCD display control circuit and the main operation keys are included. And the transmitter was constructed with the thermo sensor, measuring circuit, and the signal communication unit and is to be worn at left arm for the continuous armpit temperature monitor. For the monitoring operation, both receiver and transmitter shall be switched on. Sooner after these two parts are switched on, the wireless signal communication will be set up between receiver and transmitter. The temperature monitoring signal measured at armpit will be continuously indicated on the LCD of receiver every 15 sec. This system uses a 3.0V DC battery for operation of complete system. Whenever the battery is low, the ASIC circuit will detect the low battery condition automatically, and displays 'Low battery' in LCD display. Regarding the performance of ST323C and ST323F, it was designed and verified according to the US standard ASTM E1112-00.
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K Number
K050303Device Name
5 SEC DIGITAL CLINICAL THERMOMETER, MODELS ST8630X, ST8640X, ST8730X, ST8740X, ST8930X, ST8940X, ST8030X, ST8040X.
Manufacturer
MESURE TECHNOLOGY CO.,LTD.
Date Cleared
2005-02-25
(17 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
MESURE TECHNOLOGY CO.,LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device measures the body temperature of a patient by means of a sensor (transducer) coupled with an electronic signal amplification, conditioning and digital 1.CD (display) unit. The device is reusable and intended for oral, axillary or rectal temperature measurements.
Device Description
The 5 Sec Digital Thermometer, models ST8630X/ST8640X, ST8730X/ST8740X, ST8930X/ST8940X, ST8030X/ST8040X, and ST8B30X/ST8B40X, are the electronic thermometers by using a thermistor as the temperature sensor. The signal of sensor is calculated and displayed by an ASIC (Application Specific IC) -- controlled circuit, which is considered the hard-wire control instead of programmable control.
From the construction point of view, the digital thermometer comprises of a thermistor for measuring sensor, a reference resistor for comparison of temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermistor contacts.
This system uses a 1.5V DC battery for operation of complete system whenever the battery is low, the ASIC circuit will detect the low battery condition automatically, and displays 'Low battery' in LCD display. Regarding the performance of 5 Sec Digital Thermometer, models ST8630X/ST8640X, ST8730X/ST8740X, ST8930X/ST8940X, ST8030X/ST8040X and ST8B30X/ST8B40X it was designed and verified according to the US standard ASTM E 1112-00.
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K Number
K042627Device Name
EAR THERMOMETER MODELS ST61, ST62, ST63, ST64, AND ST65
Manufacturer
MESURE TECHNOLOGY CO.,LTD.
Date Cleared
2004-10-18
(21 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
MESURE TECHNOLOGY CO.,LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device measures the body temperature from the auditory canal of of a patient by means of an infrared sensor coupled with an electronic signal amplification, conditioning and digital LCD (display) unit. The device is reusable and intended for home use on people of all ages.
Device Description
The Mesure ear thermometer, models ST61, ST62, ST63, ST64, and ST64, are the handheld electronic thermometers that measures the temperature through the opening of the auditory canal by using a thermopile as the temperature sensor. The signal of sensor is calculated and displayed by an ASIC (Application Specific IC) - controlled circuit, which is considered the hard-wire control instead of programmable control.
From the construction point of view, the ear thermometer comprises of a thermopile for the measuring sensor, a reference thermistor for comparison of temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermopile sensor detect the ear canal temperature through the infrared.
This system uses a 3.0 V DC battery for operation of complete system whenever the battery is low, the ASIC circuit will detect the low battery condition automatically, and displays 'Low battery' in LCD display. Regarding the performance of ST61, ST62, ST63,ST64 and ST65, they were designed and verified according to the US standard ASTM E 1965-00.
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K Number
K042013Device Name
DIGITAL CLINICAL THERMOMETER, MODELS ST-8A3C AND ST-8A3F
Manufacturer
MESURE TECHNOLOGY CO.,LTD.
Date Cleared
2004-09-08
(43 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
MESURE TECHNOLOGY CO.,LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device measures the body temperature of a patient by means of a sensor (transducer) coupled with an electronic signal amplification, conditioning and digital LCD (display) unit. The device is reusable and intended for oral, axillary or rectal temperature measurements.
Device Description
The digital clinical thermometer, models ST-8A3C, and ST-8A3F, are the electronic thermometers by using a thermistor as the temperature sensor. The signal of sensor is calculated and displayed by an ASIC (Application Specific IC) – controlled circuit, which is considered the hard-wire control instead of programmable control. From the construction point of view, the digital thermometer comprises of a thermistor for measuring sensor, a reference resistor for comparison of temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermistor contacts. This system uses a 1.5V DC battery for operation of complete system whenever the battery is low, the ASIC circuit will detect the low battery condition automatically, and displays 'Low battery' in LCD display.
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K Number
K023956Device Name
THERMOMETER MODELS ST313C/F, ST314C/F, ST323C/F, ST324C/F, ST333C/F, ST334C/F
Manufacturer
MESURE TECHNOLOGY CO.,LTD.
Date Cleared
2004-06-17
(568 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
MESURE TECHNOLOGY CO.,LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The wireless temperature monitor, model ST313C/F, ST314C/F are the battery-operated electronic devices with intended use of measuring human body temperature precisely. This device is reusable and intended for wrist and abdomen temperature measurement of the baby less than eight years old, and the baby of eight years old.
Device Description
The Wireless temperature monitor, model ST-314C/F, are the electronic thermometers by using a thermistor as the temperature sensor. The signal of sensor is calculated and displayed by an ASIC (Application Specific IC) - controlled circuit, which is considered the hard-wire control instead of programmable control. From the construction point of view, the digital thermometer comprises of a thermistor for measuring sensor, a reference resistor for comparison of temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermistor contacts. This system uses a 3.0V DC battery for operation of complete system whenever the battery is low, the ASIC circuit will detect the low battery condition automatically, and displays 'Low battery' in LCD display. Reqarding the performance of ST-314C/F, it was designed and verified according to the US standard ASTM E1112-98.
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K Number
K041056Device Name
10-SECOND DIGITAL THERMOMETER, MODELS ST87, ST89, ST80, ST88
Manufacturer
MESURE TECHNOLOGY CO.,LTD.
Date Cleared
2004-05-12
(19 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
MESURE TECHNOLOGY CO.,LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device measures the body temperature of a patient by means of a sensor coupled with an electronic signal amplification, conditioning and digital LCD (display) unit. The device is reusable and intended for oral, axillary or rectal temperature measurements for home use on people of all ages.
Device Description
The 10-second digital thermometer, ST87, ST89, ST80, and ST8B, are the electronic thermometers by using a the temperature sensor. The signal of sensor is calculated and displayed by an ASIC (Application Specific IC) - controlled circuit, which is considered the hard-wire control instead of programmable control. From the construction point of view, the digital thermometer comprises of a thermistor for measuring sensor, a reference resistor for comparison of temperature, a buzzer for sounding effect an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermistor contacts. This system uses a 1.5V DC battery for operation of complete system whenever the battery is low, the ASIC circuit will detect the low battery condition automatically, and displays 'Low battery' in LCD display. Regarding the performance of ST87, ST89, ST80, and ST8B, it was designed and verified according to the US standard ASTM E 1112-98.
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