Eko Model E5 System (EME5), Eko DUO

Eko Model E5 System (EME5), Eko DUO is an FDA 510(k)-cleared medical device (K170874) manufactured by Eko Devices, 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 May 18, 2017. Regulation: 8.