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510(k) Data Aggregation

    K Number
    K030464
    Device Name
    GEM, MODEL 004110
    Manufacturer
    COLLINS MEDICAL, INC.
    Date Cleared
    2003-03-14

    (30 days)

    Product Code
    BZG
    Regulation Number
    868.1840
    Type
    Special
    Panel
    Anesthesiology (AN)
    Reference & Predicate Devices
    K992743,K942211
    Why did this record match?
    Reference Devices :

    K992743, K942211

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

    The GEM is intended to be used for diagnostic use in the treatment of pulmonary illnesses with an intended use and indication for use as a configurable, non-invasive pulmonary function tester (PFT) testing system.. The GEM is indicated for use in: pulmonary function testing.
    The Collins GEM (Gas Exchange Module) is a Pulmonary Function Test System. is intended as a configurable, non-invasive pulmonary function tester (PFT). These tests are suitable for both pediatric and adult patient testing. Compatible with the Collins' Body Plethysmograph as an optional module.

    Device Description

    The GEM (Gas Exchange Module) is a configurable, non-invasive pulmonary function tester (PFT) testing system. It includes a spirometer (pneumotach), gas analyzers (infrared for CO, CO2, CH4 and electrochemical for O2), and associated electronics.

    AI/ML Overview

    The Collins GEM (Gas Exchange Module) is a diagnostic spirometer intended for use in pulmonary function testing.

    Here is a summary of the acceptance criteria and the study information based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance:

    Feature/ParameterAcceptance Criteria (Standard/Reference)Reported Device Performance
    Spirometer Metrics
    Resistance (Pneumotach)
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