(47 days)
The devices models DT-K11B, DT-K111B, DT-K111D, DT-111D, DT-111G, DT-11G, DT-Y111D are electronic clinical thermometer intended to measure the human body temperature in regular mode orally, rectally or under the arm, the devices are reusable for clinical or home use on people of all ages.
Rapid digital thermometer DT-K11B, Rapid digital flexible thermometer DT-K111B DT-K111D, Digital flexible thermometer DT-111G DT-111D, Digital Thermometer (Water-proof) DT-11G, Predictive Digital Thermometer DT-Y111D
The provided text outlines the FDA's 510(k) clearance for several digital thermometers. While it confirms the clearance and lists the indications for use, it does not include detailed information about the acceptance criteria and the study that proves the device meets those criteria.
Therefore, I cannot provide the requested information from the given text. The document is an FDA clearance letter, not a detailed technical report of the device's validation study.
To answer your request, I would need a different type of document, such as:
- A summary of safety and effectiveness data (SSE) submitted to the FDA.
- A clinical study report.
- A test report detailing performance validation.
§ 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.