ABBY II PATIENT MONITOR OR VITAL SIGNS M

ABBY II PATIENT MONITOR OR VITAL SIGNS M is an FDA 510(k)-cleared medical device (K801515) manufactured by Abbott Medical Electronics 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 July 7, 1980. Regulation: 8.