Cleared Traditional

Zio AT ECG Monitoring System, ZEUS System

K181502 · iRhythm Technologies, Inc. · Cardiovascular
Aug 2018
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K181502 is an FDA 510(k) clearance for the Zio AT ECG Monitoring System, 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 August 29, 2018, 83 days after receiving the submission on June 7, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K181502 FDA.gov
FDA Decision Cleared SESE
Date Received June 07, 2018
Decision Date August 29, 2018
Days to Decision 83 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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