Eko Low Ejection Fraction Tool (ELEFT)

Eko Low Ejection Fraction Tool (ELEFT) is an FDA 510(k)-cleared medical device (K233409) manufactured by Eko Health, 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 March 27, 2024. Regulation: 8.