HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE

HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE is an FDA 510(k)-cleared medical device (K140096) manufactured by Hmicro, 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 July 23, 2014. Regulation: 8.