ALGO 3 NEWBORN HEARING SCREENER

ALGO 3 NEWBORN HEARING SCREENER is an FDA 510(k)-cleared medical device (K013137) manufactured by Natus Medical, 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 October 15, 2001. Regulation: 8.