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510(k) Data Aggregation

    K Number
    K051572
    Device Name
    KOKO LEGEND
    Manufacturer
    PULMONARY DATA SERVICES, INC.
    Date Cleared
    2005-11-17

    (156 days)

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

    PULMONARY DATA SERVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KoKo LEGEND is intended to be used for diagnostic use in the pulmonary function testing (PFT) with an intended use and indication for use as a configurable, non-invasive pulmonary function tester (PFT) testing system. The KoKo LEGEND is indicated for use in: pulmonary function testing. The KoKo LEGEND (Diagnostic Spirometer) is an Office Spirometer. It is intended as a configurable, portable, noninvasive pulmonary function tester (PFT) system. These tests are suitable for both pediatric and adult patient testing.
    Device Description
    The KoKo LEGEND is a configurable, non-invasive pulmonary function tester (PFT) testing system. It is a diagnostic spirometer.
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