Cleared Traditional

CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES

K101576 · Team Innovations, Inc. · Cardiovascular

Jul 2010

Decision

45d

Days

Class 2

Risk

About This 510(k) Submission

K101576 is an FDA 510(k) clearance for the CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES, a Electrode, Electrocardiograph (Class II — Special Controls, product code DRX), submitted by Team Innovations, Inc. (West Allis, US). The FDA issued a Cleared decision on July 22, 2010, 45 days after receiving the submission on June 7, 2010. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2360.

Submission Details

510(k) Number	K101576 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 07, 2010
Decision Date	July 22, 2010
Days to Decision	45 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF