PO 2 LYTRODE

PO 2 LYTRODE is an FDA 510(k)-cleared medical device (K843538) manufactured by Polystan C/O Vitalcor, 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 October 17, 1984. Regulation: 8.