BIO-LOG 8+1 AMBULATORY PHYSIOLOGIC RECORDER

BIO-LOG 8+1 AMBULATORY PHYSIOLOGIC RECORDER is an FDA 510(k)-cleared medical device (K864928) manufactured by Bio-Scan, 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 March 30, 1987. Regulation: 8.