DIGITRACE(TM) HOME MONIT COMP/ELB(TM) EEG LUNCH BX

DIGITRACE(TM) HOME MONIT COMP/ELB(TM) EEG LUNCH BX is an FDA 510(k)-cleared medical device (K910771) manufactured by New England Medical Instruments, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 17, 1991. Regulation: 8.