GUARDIAN MONITOR (CARDIOVASCULAR)

GUARDIAN MONITOR (CARDIOVASCULAR) is an FDA 510(k)-cleared medical device (K803282) manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 26, 1981. Regulation: 8.