MODEL 3500 INFANT RESPIRATION & HEART RATE MONITOR

MODEL 3500 INFANT RESPIRATION & HEART RATE MONITOR is an FDA 510(k)-cleared medical device (K864261) manufactured by Bio-Dyne, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 26, 1987. Regulation: 8.