Aproved: FDA + CE Bi-level device is indicated for treatment of sleep apnea hypopnea syndrome in patients weighing more than 66lb (30kg). It is intended both for home use and hospital use. The humidifier is intended for single patient use in the home environment and re-use in a hospital/institutional environment
CE marked and FDA 510(K) Number K192123. The SARS-CoV-2 IgM/IgG Ab Rapid Test is used to detect the IgM and IgG antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in human serum, plasma, or whole blood sample qualitatively. It is to be used as an aid in the diagnosis of infectious disease. 40T/box, 48 boxes/ctn