Cleared Traditional

ZIO PATCH

K121319 · iRhythm Technologies, Inc. · Cardiovascular
Jul 2012
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K121319 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 July 18, 2012, 77 days after receiving the submission on May 2, 2012. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2800.

Submission Details

510(k) Number K121319 FDA.gov
FDA Decision Cleared SESE
Date Received May 02, 2012
Decision Date July 18, 2012
Days to Decision 77 days
Submission Type Traditional
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