Cleared Traditional

Zio ECG Utilization Software (ZEUS) System

K202527 · iRhythm Technologies, Inc. · Cardiovascular
May 2021
Decision
262d
Days
Class 2
Risk

About This 510(k) Submission

K202527 is an FDA 510(k) clearance for the Zio ECG Utilization Software (ZEUS) System, a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by iRhythm Technologies, Inc. (San Francisco, US). The FDA issued a Cleared decision on May 21, 2021, 262 days after receiving the submission on September 1, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K202527 FDA.gov
FDA Decision Cleared SESE
Date Received September 01, 2020
Decision Date May 21, 2021
Days to Decision 262 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQK — Computer, Diagnostic, Programmable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1425

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