This app is specifically intended for study participants in the ADAURA2 study only. The Masimo MightySat Rx Pulse (model 9909 or 9907) Oximeter is a Class B digital device, pursuant to part 15 of the FCC Rules and has been been tested and found to comply with the Class B limits for medical devices according to the EN 60601-1-2: 2007, Medical Device Directive 93/42/EEC. The device has Declaration of Comformity (CE) for the following countries: Argentina, Brazil, Canada, Germany, Italy, Japan, Malaysia, Poland, Romania, Singapore, South Korea, Spain, Taiwan, Thailand, Turkey, United Kingdom, and the United States
