LYTENING(TM) 5, LYTENING(TM) SYSTEM 30

LYTENING(TM) 5, LYTENING(TM) SYSTEM 30 is an FDA 510(k)-cleared medical device (K896526) manufactured by Baxter Healthcare Corp. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 1, 1990. Regulation: 8.