SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE

SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE is an FDA 510(k)-cleared medical device (K924709) manufactured by Air-Shields, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 16, 1996. Regulation: 8.