(238 days)
RC002 Remote Infrared Themometer is an infrared thermoniter for body surface and forchead temperature measurement for infants and adults without contacting to human body. It ean be used by consumers in household covinnment and doctor in clinic as reference.
RC002 Remote Infrared Thermometer
The provided text is a 510(k) premarket notification approval letter for the "RC002 Remote Infrared Thermometer." This type of document generally contains information about the regulatory approval, but it does not typically include detailed acceptance criteria, study methodologies, or performance data as requested in your prompt. The letter confirms substantial equivalence to a predicate device but does not present the underlying data from the studies conducted to establish that equivalence.
Therefore, I cannot extract the requested information from this document. The letter itself is documentation of regulatory approval, not a scientific study report.
If you have access to the actual 510(k) submission document for K090361, it might contain the detailed study information you are looking for.
§ 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.