Cleared Traditional

Zio AT? device (A100A1001)

K240177 · iRhythm Technologies, Inc. · Cardiovascular
Oct 2024
Decision
281d
Days
Class 2
Risk

About This 510(k) Submission

K240177 is an FDA 510(k) clearance for the Zio AT? device (A100A1001), a Detector And Alarm, Arrhythmia (Class II — Special Controls, product code DSI), submitted by iRhythm Technologies, Inc. (San Francisco, US). The FDA issued a Cleared decision on October 30, 2024, 281 days after receiving the submission on January 23, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K240177 FDA.gov
FDA Decision Cleared SESE
Date Received January 23, 2024
Decision Date October 30, 2024
Days to Decision 281 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DSI — Detector And Alarm, Arrhythmia
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1025

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