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    FDA 510(k) K163512, Zio AT ECG Monitoring System, by iRhythm Technologies, Inc.

    FDA 510(k) K163512, Zio AT ECG Monitoring System, by iRhythm Technologies, Inc.

    $3,500.00 USD
    $3,500.00 USD
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    Device Classification Name: Outpatient Cardiac Telemetry
    510(k) Number: K163512
    Device Name: Zio AT ECG Monitoring System
    Applicant: iRhythm Technologies, Inc.
    Regulation Number: 870.1025
    Classification Product Code: QYX
    Date Received: 12/15/2016
    Decision Date: 06/02/2017
    Decision: Substantially Equivalent (SESE)
    Regulation Medical Specialty: Cardiovascular
    510k Review Panel: Cardiovascular

    Total number of pages: 2,996
    Fully redacted pages: 1
    Content pages: 2,995

    PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.

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