ECG RECALL & EDIT PRODUCT VERSION-A3601

ECG RECALL & EDIT PRODUCT VERSION-A3601 is an FDA 510(k)-cleared medical device (K802103) manufactured by General Electric Co.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 25, 1980. Regulation: 8.