RESPIRATION/HEART RATE MONITOR MODEL 9500/9550

RESPIRATION/HEART RATE MONITOR MODEL 9500/9550 is an FDA 510(k)-cleared medical device (K903020) manufactured by Aequitron Medical, 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 April 9, 1991. Regulation: 8.