(316 days)
The Infrared Thermometer (model of AET-R811,AET-R832,AET-R842,AET-R852,AET-R862) is intended for measuring human body temperature of people aged 3 months and above by detecting infract contact with the forehead and ear canal in the home or hospital environment.
The Infrared Thermometer (model of AET-R101, AET-R151, AET-R1A3, AET-R1A6, AET-R1C1) is intended for measuring human body temperature of people aged 3 months and above by detecting infrared heat from the ear canal in the home or hospital environment.
Not Found
The provided text is a 510(k) premarket notification clearance letter for an Infrared Thermometer. It does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria in the requested format.
The document states that the FDA has reviewed the submission and determined that the device is substantially equivalent to legally marketed predicate devices. However, this letter itself does not include the detailed test results, performance data, or study designs that would typically be found in the actual 510(k) submission or an associated test report.
Therefore, I cannot provide the requested information based on the given text. To answer your questions, I would need access to the full 510(k) submission, including the performance testing and clinical data sections.
§ 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.