510(k) K140096

HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE by Hmicro, Inc. — Product Code DRX

K140096 is an FDA 510(k) premarket notification submitted by Hmicro, Inc. for the device "HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE". The FDA issued a decision of Substantially Equivalent on July 24, 2014. The device falls under product code DRX (Electrode, Electrocardiograph), a Class II device regulated under 21 CFR 870.2360. Hmicro, Inc. has at least 1 other 510(k) clearance on record.