Cerebral Oximeter

FDA product code QEM · Class II (moderate risk) · 21 CFR 870.2700 · Cardiovascular

Oximeter to measure cerebral tissue saturation

1510(k) clearances
0PMA approvals
0recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K182242VO200 – NeurOs Cerebral Oximetry SystemQEM · Traditional Mespere Lifesciences, Inc.12/26/2018SE