Cleared Traditional

ZIO PATCH, MODEL Z100

K090363 · iRhythm Technologies, Inc. · Cardiovascular
May 2009
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K090363 is an FDA 510(k) clearance for the ZIO PATCH, MODEL Z100, 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 May 8, 2009, 84 days after receiving the submission on February 13, 2009. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2800.

Submission Details

510(k) Number K090363 FDA.gov
FDA Decision Cleared SESE
Date Received February 13, 2009
Decision Date May 08, 2009
Days to Decision 84 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