Cleared Traditional

ZEUS System

K222389 · iRhythm Technologies, Inc. · Cardiovascular
Feb 2023
Decision
191d
Days
Class 2
Risk

About This 510(k) Submission

K222389 is an FDA 510(k) clearance for the 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 February 15, 2023, 191 days after receiving the submission on August 8, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K222389 FDA.gov
FDA Decision Cleared SESE
Date Received August 08, 2022
Decision Date February 15, 2023
Days to Decision 191 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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