PHYSIOLOGICAL MONITOR, MODELS 401,402 & 403

PHYSIOLOGICAL MONITOR, MODELS 401,402 & 403 is an FDA 510(k)-cleared medical device (K862647) manufactured by Ivy Biomedical Systems, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 17, 1986. Regulation: 8.