Cleared Special

ZIO PATCH

K113862 · iRhythm Technologies, Inc. · Cardiovascular
Feb 2012
Decision
38d
Days
Class 2
Risk

About This 510(k) Submission

K113862 is an FDA 510(k) clearance for the ZIO PATCH, 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 February 6, 2012, 38 days after receiving the submission on December 30, 2011. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2800.

Submission Details

510(k) Number K113862 FDA.gov
FDA Decision Cleared SESE
Date Received December 30, 2011
Decision Date February 06, 2012
Days to Decision 38 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

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