FDA approved 510k non-contact infrared thermometer with local medical device license
Applicable regulations and laws
ASTM E 1965-98 (Reapproved 2009)
Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
ISO80601-2-56 First Edition 2009-10-01
Medical Electrical Equipment - Part 2-56: Particular Requirements For Basic Safety And Essential Performance Of Clinical Thermometers For Body Temperature Measurement. (General Plastic Surgery/General Hospital)