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510(k) Data Aggregation

    K Number
    K974526
    Device Name
    EASYBLOOD GAS ANALYZER
    Manufacturer
    MEDICA CORP.
    Date Cleared
    1998-02-05

    (65 days)

    Product Code
    CHL
    Regulation Number
    862.1120
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The EasyBloodGas analyzer is designed for laboratory use, making direct measurements of pH (hydrogen ion activity), PCO2 (partial pressure of carbon dioxide) and PO2 (partial pressure of oxygen) on whole blood samples from syringes or capillary tubes.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the "Easy Blood Gas Analyzer." It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain specific information regarding acceptance criteria, study details (like sample sizes, ground truth establishment, or expert qualifications), or performance results from a study.

    Therefore, I cannot fulfill your request for the detailed table and study description based solely on the provided text. The document confirms the device's clearance for marketing but does not delve into the technical validation study results that would typically be found in the 510(k) submission itself (which is not provided here).

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