ADAPTATION OF KANTRON 40 CC. PDLIAB

ADAPTATION OF KANTRON 40 CC. PDLIAB is an FDA 510(k)-cleared medical device (K820166) manufactured by Kontron Instruments, Inc.. 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 28, 1982. Regulation: 8.