COBE SATURATION/HEMATOCRIT MONITOR W/ FIBER OPTIC

COBE SATURATION/HEMATOCRIT MONITOR W/ FIBER OPTIC is an FDA 510(k)-cleared medical device (K902758) manufactured by Cobe Laboratories, 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 August 22, 1990. Regulation: 8.