MODELS 78504A & 78508A PATIENT MON. SYS

MODELS 78504A & 78508A PATIENT MON. SYS is an FDA 510(k)-cleared medical device (K821368) manufactured by Hewlett-Packard Co.. 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 24, 1982. Regulation: 8.