OBER2 MONITOR, EYE MOVEMENT (OPHTHALMIC)

OBER2 MONITOR, EYE MOVEMENT (OPHTHALMIC) is an FDA 510(k)-cleared medical device (K902954) manufactured by Permobil AB. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 22, 1990. Regulation: 8.