Search Results

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.

Ask a specific question about this device