CYBERLITH IX QUANTUM-UNIPOLAR CARDIAC

CYBERLITH IX QUANTUM-UNIPOLAR CARDIAC is an FDA 510(k)-cleared medical device (K823863) manufactured by Intermedics, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on March 9, 1983. Regulation: 8.