BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS

BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS is an FDA 510(k)-cleared medical device (K901548) manufactured by Shiley, 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 13, 1991. Regulation: 8.