Cleared Traditional

ZIO SR ECG Monitoring Service

K143513 · iRhythm Technologies, Inc. · Cardiovascular
Jun 2015
Decision
190d
Days
Class 2
Risk

About This 510(k) Submission

K143513 is an FDA 510(k) clearance for the ZIO SR ECG Monitoring Service, a Recorder, Magnetic Tape, Medical (Class II — Special Controls, product code DSH), submitted by iRhythm Technologies, Inc. (San Francisco, US). The FDA issued a Cleared decision on June 19, 2015, 190 days after receiving the submission on December 11, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2800.

Submission Details

510(k) Number K143513 FDA.gov
FDA Decision Cleared SESE
Date Received December 11, 2014
Decision Date June 19, 2015
Days to Decision 190 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DSH — Recorder, Magnetic Tape, Medical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2800