POSEIDON CARDIAC MONITORING SYSTEM (PCMS)

POSEIDON CARDIAC MONITORING SYSTEM (PCMS) is an FDA 510(k)-cleared medical device (K964408) manufactured by Instromedix, 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 July 22, 1997. Regulation: 8.