AUTOMATED PHYSIOLOGIC PROFILER

AUTOMATED PHYSIOLOGIC PROFILER is an FDA 510(k)-cleared medical device (K780530) 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 April 27, 1978. Regulation: 8.