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510(k) Data Aggregation
K Number
K190717Device Name
Infrared Thermometer, model: PC808
Manufacturer
Date Cleared
2019-12-13
(268 days)
Product Code
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Pacom Medical Instruments Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Infrared Thermometer (Model: PC808) is intermittent measurement of ear and forehead temperature at home. It can be used for anybody, e.g. for new-born, for children and for adults. The thermometer is touch for the forehead measurement site.
Device Description
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K Number
K172889Device Name
Infrared Thermometer
Manufacturer
Date Cleared
2018-05-25
(246 days)
Product Code
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Pacom Medical Instruments Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Infrared thermometer Model PC868 can measure body temperature from the forehead of infants and adults without contact to the human body, it can be used by consumers in household environment and by doctors in the clinic.
Device Description
All objects above absolute zero temperature emits certain percentage of infrared radiation energy based on its temperature. The amount of the radiation energy and the distribution of the wavelength have very closely relationship. When human forehead's temperature in 36-37°C, it emits wavelength 9-13um of infrared radiation. Based on this principle, according to the relationship between surface forehead temperature, we are able to measure the human forehead's actual temperature through measuring surface forehead temperature. Therefore, the subject device is able to measure the temperature of a person by the energy the person emits. The predicate device KI-8280, use the same detection principle to measure the patient's temperature.
These thermometers are a kind of measurement device that utilize infrared radiation to measure forehead and object temperature. The Infrared Thermometers main function as following:
- Forehead and object temperature measure functions
- Have wide range of temperature readings: from 32.0°Cto 42.9°C
- The big LCD display can clear showing the measure result.
- Have memory function
- Low battery indicator
- Have backlight function
- Have ambient temperature detection function
The power supply of Infrared Thermometer is DC 3.0 V, which is offered by two AAA batteries.
This thermometer uses thermopile as the temperature sensor. The enclosure cover is made of ABS plastic material. The thermometer mainly includes the following components: MCU, PCB, LCD, Infrared Sensor, Probe, Batteries, Buzzer, Backlight and Enclosure Cover.
There are only one patient contacting materials: ABS plastic. The material also meet the test requirements of ISO10993-5 (In vitro cytotoxicity) and ISO10993-10 (Irritation and delayedtype hypersensitivity).
The subject device of PC868 also use the focusing design to collect the infrared emitted from nearby area of object surface. This mechanism make the subject device have the ability to detect the object surface temperature.
The compact, small and light-weight design, the Shenzhen Pacom Medical Instruments Co., Ltd. Infrared Thermometer, model PC868, enables to provide safe and reliable result and offers a very good clinical accuracy for human body temperature measurements.
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