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510(k) Data Aggregation
K Number
K152905Device Name
ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer
Manufacturer
Date Cleared
2016-07-20
(293 days)
Product Code
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
ARC DEVICES LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ARC InstaTemp™ is an infrared thermometer that measures from the forehead in both infants and adults without contacting the human body.
The ARC InstaTemp MD™ is an infrared thermometer that measures from the forehead in both infants and adults without contacting the human body. It is intended for use by a Health Care Professional in a clinical environment. This device is not intended for home use.
Device Description
The ARC Non-Touch Thermometer is a fast, accurate and non-intrusive device for measuring a person's temperature. It uses infrared sensor technology to detect the radiated infrared energy emitted from the forehead. Therefore as soon as the sensor is held near the forehead and activated, the temperature measurement is taken by detection of the emitted infrared heat generated by the arterial blood flow.
The ARC Non-Touch Thermometer uses sensor technology that detects the emitted heat from the temporal artery in the forehead from a distance of approximately 1 inch. Once recorded an internal algorithm converts this forehead surface temperature into human body temperature and it is this temperature that is then presented to the user on the LCD screen. This temporal artery detection mechanism and the resulting conversion to body temperature characterizes the ARC Non-Touch Thermometers as an adjusted mode clinical thermometer as per ISO 80601-2-56.
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