Cleared Traditional

ZEUS (ZIO ECG UTILIZATION SERVICE) SYSTEM

K091075 · iRhythm Technologies, Inc. · Cardiovascular
Jul 2009
Decision
98d
Days
Class 2
Risk

About This 510(k) Submission

K091075 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 July 21, 2009, 98 days after receiving the submission on April 14, 2009. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K091075 FDA.gov
FDA Decision Cleared SESE
Date Received April 14, 2009
Decision Date July 21, 2009
Days to Decision 98 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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