Cleared Traditional

Zio Monitor

K202359 · iRhythm Technologies, Inc. · Cardiovascular
May 2021
Decision
275d
Days
Class 2
Risk

About This 510(k) Submission

K202359 is an FDA 510(k) clearance for the Zio Monitor, 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 21, 2021, 275 days after receiving the submission on August 19, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2800.

Submission Details

510(k) Number K202359 FDA.gov
FDA Decision Cleared SESE
Date Received August 19, 2020
Decision Date May 21, 2021
Days to Decision 275 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