PHYSIOLOGICAL MONITOR, MODELS 101,301,201,202,303A

PHYSIOLOGICAL MONITOR, MODELS 101,301,201,202,303A is an FDA 510(k)-cleared medical device (K854840) 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 May 6, 1986. Regulation: 8.