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510(k) Data Aggregation
K Number
K042631Device Name
EAR THERMOMETER, MODEL WL-320X
Manufacturer
Date Cleared
2004-12-22
(86 days)
Product Code
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
INNOVATECH, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Ear Thermometer, models WL-320X are the battery-operated electronic devices with intended use of measuring body temperature from the auditory canal of a patient by means of an infrared sensor coupled with electronic signal amplification, conditioning and a digital LCD(display) unit. The device is a reusable and intended for home use on people at all ages.
Device Description
battery-operated electronic devices with intended use of measuring body temperature from the auditory canal of a patient by means of an infrared sensor coupled with electronic signal amplification, conditioning and a digital LCD(display) unit. The device is a reusable and intended for home use on people at all ages.
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K Number
K023500Device Name
DIGITAL CLINICAL THERMOMETER, MODEL BABY TEMP/WL-3305 AND BABY TEMP (+) /WL-3306
Manufacturer
Date Cleared
2002-12-13
(56 days)
Product Code
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
INNOVATECH, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Digital Clinical Thermometer, model BABY TEMP / WL-3305 and BABY TEMP(+) WL-3306 are the battery-operated electronic devices with intended use of measuring human body temperature precisely. It can be measurement of oral, axially and rectal temperature.
Device Description
The Digital Clinical Thermometers, model BABY TEMP / WL-3305 and BABY TEMP(+) / WL-3306, 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. Basically WL-3305 and WL-3306 have the same intended use and operation function except for the different measuring range caused by some small different design in IC circuit.
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 BABY TEMP / WL-3305 and BABY TEMP(+) / WL-3306, it was designed and verified according to the US standard ASTM E1112-98.
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