Cleared Traditional

ZEUS System (Zio Watch)

K213409 · iRhythm Technologies, Inc. · Cardiovascular
Jul 2022
Decision
273d
Days
Class 2
Risk

About This 510(k) Submission

K213409 is an FDA 510(k) clearance for the ZEUS System (Zio Watch), 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 July 19, 2022, 273 days after receiving the submission on October 19, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K213409 FDA.gov
FDA Decision Cleared SESE
Date Received October 19, 2021
Decision Date July 19, 2022
Days to Decision 273 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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