38503736-d7bc-42b9-a3e3-13c79a37b2b9UpdatePublished42024-10-072018-01-17In Commercial Distribution00851908007123PrimaryGS1FaceLakeFL-420029578633LORTE TECHNOLOGIES, INC1The Facelake FL-420 finger pulse oximeter is a lightweight, portable device used for measuring both heart rate and blood oxygen levels or SpO2.falsefalsefalsefalsefalsefalsefalsetruefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationfalsetrue1-847-234-0754info@pulseoximeter.orgK08264100045607Pulse oximeterAn electrically-powered photoelectric device designed for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals are produced by light-emitting diodes (LEDs) and received by a photodetector. The device displays the SpO2 values and may also measure/display pulse rate. It is typically applied to the fingertip or around the wrist, may be single-component (with built-in probe) or multi-component (includes external probe), and may in addition wirelessly transmit measurements to a receiving location (e.g., central station, bedside monitor); it is intended to be operated by laypersons and healthcare providers.falseActiveDQAOximetertruefalse