BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM

BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM is an FDA 510(k)-cleared medical device (K954501) manufactured by Medtronic Bio-Medicus, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 15, 1996. Regulation: 8.