ELECTRONIC PACEMAKER WAVEFORM ANALYZER

ELECTRONIC PACEMAKER WAVEFORM ANALYZER is an FDA 510(k)-cleared medical device (K800696) manufactured by Instromedix, 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 August 13, 1980. Regulation: 8.