A1-A2 AMBULATORY EEG CASSETTE RECORDER

A1-A2 AMBULATORY EEG CASSETTE RECORDER is an FDA 510(k)-cleared medical device (K870432) manufactured by Grass-Telefactor Product Group. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 7, 1987. Regulation: 8.