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The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in neonatal, pediatric and adult population used in the home setting.

The device is an electronic clinical thermometer using an infrared sensor.

The provided text is a 510(k) clearance letter from the FDA for an Infrared Ear Thermometer. It does not contain the information requested about acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study details.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates that the clearance is based on substantial equivalence to an existing device, not necessarily on a detailed study proving performance against specific acceptance criteria.

Therefore, I cannot extract the requested information from the provided document.

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