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510(k) Data Aggregation

    K Number
    K090363
    Device Name
    ZIO PATCH, MODEL Z100
    Manufacturer
    IRHYTHM TECHNOLOGIES, INC.
    Date Cleared
    2009-05-08

    (84 days)

    Product Code
    DSH
    Regulation Number
    870.2800
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ZIO PATCH, MODEL Z100

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Zio TM patch is a prescription only single patient use, continuous recording ECG monitor that can be worn for up to 14 days. It is indicated for use on patients who experience transient symptoms such as syncope, palpitations, shortness of breath, or chest pains.

    Device Description

    The Zio TM patch is a prescription only single patient use, continuous recording ECG monitor that can be worn for up to 14 days.

    AI/ML Overview

    This document is a 510(k) clearance letter for the Zio™ patch Model Z100 from the U.S. FDA, dated May 8, 2009. It primarily grants market clearance and defines the indications for use. It does not contain detailed information about acceptance criteria or a study proving the device meets said criteria.

    Therefore, I cannot provide the requested information based on the provided text. The document is for regulatory clearance and states that the device is substantially equivalent to legally marketed predicate devices, but it does not include performance data or study details.

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