The Metris THD2FE is a clinical / medical grade non-contact infrared thermometer with the following FDA registration information:
- FDA Classification: THERMOMETER, ELECTRONIC, CLINICAL
- Product Code: FLL
- CLASS II MEDICAL device
- Regulation # 880.2910 for hospital specialty
- Federal registration number is 3015171186
Protect your loved ones, employees, customers and yourself with a proven product: MODEL THD2FE: engineered for outstanding accuracy, reliability and ease of use.
The THD2FE measures forehead temperature with an accuracy of ±0.4°F (0.2°C) for the range of 95-107.6°F. Scanning must be performed within 1.5 inches of the subject’s forehead and is performed in one second.
The THD2FE features a blue LED backlight so its screen is easy to see, and can be used in ambient conditions of 50-104°F with 15-85% RH.
This operates on two AAA batteries, which are included.
Precise laboratory calibration, state-of-the-art PC board design (SoiC) & manufacturing, AND 20 years of experience in thermometer technology.. delivers THE very best accuracy possible in the Clinical-Medical-Hospital Class II device category.
Independent test results by ASTM and Integrated Service Solutions [ISS] confirm that the THD2FE meets and EXCEEDS accuracy claims of +/- only 4/10th degree F error of reading. Test reports are on file for examination.
NOTE REGARDING FDA APPROVAL: The FDA has recently issued guidance providing that it does not object to the distribution and use of telethermographic systems intended for adjunctive diagnostic/initial body temperature assessment and screening during the COVD-19 pandemic where such devices do not create an undue risk. For more information, see https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/thermal-imaging-systems-infrared-thermographic-systems-thermal-imaging-cameras and https://www.fda.gov/medical-devices/emergency-situations-medical-devices/non-contact-temperature-assessment-devices-during-covid-19-pandemic. We obviously cannot now predict how long the COVID-19 pandemic will last, or what position the FDA may take on such devices in the future. You should always follow all instructions and rules when using any telethermographic system, such as those sold by TEquipment, and should consult with your attorney concerning relevant legal requirements and best practices for implementation and COVID-19 screening.”
Metris THD2FE - Infrared Forehead Thermometer, FDA 510K Cleared (Clinical/Medical/Hospital Grade Class 2) - with NIST Calibration
- Brand: NONE
- Product Code: THD2FE-NIST
- Availability: Pre-Order