BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ZEUS System

    K Number: K222389 · Decision Feb 15, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    178
    Registration Numbers
    178
    Same Product Code
    429
    Applicant Total
    18
    Review Days
    191

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    Basic Information

    Device Name
    ZEUS System
    K Number
    K222389
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1425
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    iRhythm Technologies, Inc.
    Date Received
    August 8, 2022
    Decision Date
    February 15, 2023
    Product Code
    DQK
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DQK Computer, Diagnostic, Programmable

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    Other Clearances by iRhythm Technologies, Inc.

    K Number Device Name
    K252859 ZEUS Platform (FG0501US)
    K243650 Zio® monitor (DFG0001)
    K240177 Zio AT® device (A100A1001)
    K240029 Zio AT® device (A100A1001)
    K213409 ZEUS System (Zio Watch)
    K202527 Zio ECG Utilization Software (ZEUS) System
    K202359 Zio Monitor
    K190593 Zio XT ECG Monitoring System, Zio AT ECG Monitoring System
    K181502 Zio AT ECG Monitoring System, ZEUS System
    K163512 Zio AT ECG Monitoring System
    Search all 18 clearances from iRhythm Technologies, Inc. →