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The Fluke 67 MAX accuracy complies with and is accuracy tested in accordance with ASTM
E1965-98 and ISO 80601-2-56 standards. The Fluke 67 MAX meets the performance and
labeling requirements provided in the U.S. Food and Drug Administration's April 2020
Enforcement Policy for Clinical Electronic Thermometers During the Coronavirus Disease
2019 (COVID-19) Public Health Emergency. The Fluke 67 MAX is not FDA 510(k) cleared,
approved, or authorized.
The product has not been tested on children and thus, may be subject to error when
used on children under 18 years of age.
Indications for Use
The Fluke 67 MAX is a clinical non-contact infrared thermometer intended for the
measurement and monitoring of human body temperature. The device is intended for use in
adults in both healthcare and non-healthcare settings. The measurement should not be
solely or primarily relied upon to diagnose or exclude a diagnosis of any disease.
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