SAAD PATIENT MONITOR (SPM)

SAAD PATIENT MONITOR (SPM) is an FDA 510(k)-cleared medical device (K133222) manufactured by Hanin Medical Services Co., Ltd.. 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 5, 2014. Regulation: 8.