ESWALLOW USA ELECTRODE,ESWALLOW USA LEADWIRE

ESWALLOW USA ELECTRODE,ESWALLOW USA LEADWIRE is an FDA 510(k)-cleared medical device (K113375) manufactured by Eswallow USA. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 24, 2013. Regulation: 8.