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510(k) Data Aggregation

    K Number
    K093174
    Device Name
    SPIROPALM
    Manufacturer
    COSMED S.R.L.
    Date Cleared
    2010-02-26

    (141 days)

    Product Code
    BZG
    Regulation Number
    868.1840
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SPIROPALM

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

    The COSMED Spiropalm and Spiropalm Plus pulmonary function testing system are Spirometers for performing the basic lung function tests (basic spirometry: Forced Vital Capacity, Slow Vital Capacity, Maximal Voluntary Ventilation) and Pulse Oximetry tests in the physician's office or a hospital setting.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA to COSMED S.R.L. regarding their Spiropalm Series device. This letter indicates FDA's determination of substantial equivalence to predicate devices.

    However, the document does NOT contain information about specific acceptance criteria for a study, the results of such a study, the sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details about training sets. These types of details are typically found in the 510(k) submission itself (which is not provided) and summarized in an FDA summary document or a scientific publication, rather than in the substantial equivalence determination letter.

    Therefore, I cannot provide the requested information based on the given text.

    The provided document does not contain the information necessary to answer the questions regarding acceptance criteria and study details.

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