Search Results

The NC Thermometer (Gen3) is used orally for the intermittent measurement and monitoring of human body temperature. The device can be used by adults and children over the age of 5 years old.

The purpose of this traditional 510(k) premarket notification is to introduce NC° Thermometer (Gen3). NC° Thermometer (Gen3) is a battery powered, thermistor- based Bluetooth Low Energy (BLE) and Near Field Communication (NFC) enabled adjusted mode digital thermometer that uses a predictive algorithm for the measurement and monitoring of human body temperature. Body temperature is measured orally with the NC° Thermometer. Temperature measurements are displayed on the thermometer and can also (optionally) be transmitted to the Natural Cycles application on the user's smartphone by women over the age of 18. The compatible application displays the thermometer temperature value. The thermometer is reusable for home use on adults and children ages 5 and above. The thermometer is made of biocompatible metals and resins. The thermometer consists of a Negative Temperature Coefficient (NTC) thermistor located in the probe tip to sense human body temperature, three input user facing buttons, an output buzzer for audio indications, a screen for user display, and back lights for illuminating the buttons.