IMPACT.WF MOBILE WAVEFORM RECEIVING SYSTEM

IMPACT.WF MOBILE WAVEFORM RECEIVING SYSTEM is an FDA 510(k)-cleared medical device (K994430) manufactured by General Electric Medical Systems Information Techn. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 27, 2000. Regulation: 8.