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510(k) Data Aggregation

    K Number
    K020004
    Device Name
    CLINDATALINK VERSION 1.0 FOR SPIROMETRY
    Manufacturer
    COMPLEWARE CORP.
    Date Cleared
    2002-07-24

    (203 days)

    Product Code
    BZG
    Regulation Number
    868.1840
    Why did this record match?
    Applicant Name (Manufacturer) :

    COMPLEWARE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ClinDataLinkTM Version 1.0 for Spirometry is an application software that will collect spirometry data for clinical research studies in male/females, pediatrics to adults, and measure FVC, MVV, and SVC, in a hospital, clinic, or home use environment. Prescription device by a physician.
    Device Description
    ClinDataLink Version 1.0 is a software application that will be used to collect spirometry data for clinical research studies using QRS Diagnostics, LLC Type II PCMCIA cards and software development kit. ClinDataLink will capture demographic data, spirometry data (FVC, SVC, and MVV) and time/date of visits based upon Protocol Wizard.
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