Cleared Special

ZEUS (ZIO ECG Utilization Service) System

K142681 · iRhythm Technologies, Inc. · Cardiovascular
Nov 2014
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K142681 is an FDA 510(k) clearance for the ZEUS (ZIO ECG Utilization Service) 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 November 21, 2014, 63 days after receiving the submission on September 19, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K142681 FDA.gov
FDA Decision Cleared SESE
Date Received September 19, 2014
Decision Date November 21, 2014
Days to Decision 63 days
Submission Type Special
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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