(30 days)
The TaiDoc TD11 series Ear/Skin/Surface IR Thermometers, Clever TD-1112 Ear/Skin/Surface IR Thermometer, FORA IR16/17 Ear Thermometers are electronic thermometer using an infrared sensor to detect human body temperature from the ear canal on people of all ages and for use in the home. It is also available to detect object's surface temperature including human skin.
electronic thermometer using an infrared sensor
This document is a 510(k) premarket notification acceptance letter from the FDA for several infrared thermometers. It does not contain any information about acceptance criteria for device performance, nor does it describe any study results.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval and substantial equivalence to predicate devices, not on the technical performance of the devices against specific criteria or the details of any studies proving that performance.
§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.