www.fdanews.com/articles/190685-fda-clears-masimos-co-oximeter
FDA Clears Masimo’s CO-Oximeter
March 25, 2019
Masimo received 510(k) clearance for its Rad-67 Pulse CO-Oximeter, a device used to measure the oxygen carrying state of hemoglobin in a blood sample.
The portable device performs spot-check monitoring using its DCI-mini sensor, which analyzes total hemoglobin, carboxyhemoglobin, methemoglobin and arterial oxygen saturation.
The single-device solution is suited for use in both clinical and non-clinical settings, such as emergency rooms, physician’s offices and pre- and post-surgery situations.