(194 days)
The infrared thermometer (model of UFR102) is intended for measurement of ear and forehead temperature. It can be used for anybody, e.g. for new-born, for children and for adults.
The infrared non-contact thermometer (model of UFR107) is intended for measurement forehead temperature at home and hospital, for patients of all ages.
Not Found
The provided text describes a 510(k) premarket notification for an Infrared Thermometer, focusing on its regulatory status and indications for use. It does not contain any information about acceptance criteria, device performance testing, sample sizes for training or test sets, expert involvement, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance. Therefore, I cannot generate the requested information based on the provided text.
To answer your request, I would need a document that describes the clinical performance study or validation of the infrared thermometer.
§ 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.