RAYDEN MEDICAL MINI PULSE VOLUME RECORD

RAYDEN MEDICAL MINI PULSE VOLUME RECORD is an FDA 510(k)-cleared medical device (K833155) manufactured by Burditt & Calkins-Siemens-Elema. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 25, 1984. Regulation: 8.