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510(k) Data Aggregation

    K Number
    K072061
    Device Name
    MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY
    Manufacturer
    VIASYS HEALTHCARE GMBH
    Date Cleared
    2008-04-22

    (270 days)

    Product Code
    JEH
    Regulation Number
    868.1760
    Type
    Traditional
    Panel
    Anesthesiology (AN)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY

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

    The Masterscreen PFT Body is intended to be used for measurement and data collection of lung function parameters. The system performs cooperation-dependent pulmonary function tests which include Spirometry/Flow-Volume/Resistance measurements, lung diffusion measurements and bodyplethysmography measurement. The device provides data / information and supports help for a diagnosis.

    MasterScreen PFT (Clinical Trial version) includes Spirometry/Flow-Volume/Resistance measurements and lung diffusion measurements with individual access rights defined for different user roles (e.g. Investigator, doctor, study nurse, trainer and service personnel).

    MasterScreen PFT includes Spirometry/Flow-Volume/Resistance and lung diffusion measurements.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any study details. It is a 510(k) premarket notification letter from the FDA to VIASYS Healthcare GmbH concerning their MasterScreen PFT devices. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory compliance requirements.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on this input.

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