(32 days)
The Timex ACCU-CURVE and Traditional Digital Oral Thermometers are electronic thermometers to measure patient temperature orally. Targeted users include professional and over-the-counter users.
Timex ACCU-CURVE Digital Oral Thermometer, Timex Oral Digital Thermometer
The provided document is a 510(k) clearance letter for the Timex ACCU-CURVE Digital Oral Thermometer and Timex Oral Digital Thermometer. It confirms that the FDA has found the device to be substantially equivalent to legally marketed predicate devices.
However, this document does not contain information regarding detailed acceptance criteria or a study proving that the device meets specific performance criteria. The letter acknowledges a "Section 510(k) premarket notification" which would typically include such study information, but the study details themselves are not present in the provided text.
Therefore, I cannot extract the requested information from this document. To fulfill your request, I would need access to the actual 510(k) submission document that details the performance studies conducted for these thermometers.
§ 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.