Cleared Traditional

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

K140096 · Hmicro, Inc. · Cardiovascular

Jul 2014

Decision

191d

Days

Class 2

Risk

About This 510(k) Submission

K140096 is an FDA 510(k) clearance for the HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE, a Electrode, Electrocardiograph (Class II — Special Controls, product code DRX), submitted by Hmicro, Inc. (Los Altos, US). The FDA issued a Cleared decision on July 24, 2014, 191 days after receiving the submission on January 14, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2360.

Submission Details

510(k) Number	K140096 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 14, 2014
Decision Date	July 24, 2014
Days to Decision	191 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF