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510(k) Data Aggregation

    K Number
    K973544
    Device Name
    VACU*MED, GOLD EDITION CARBON DIOXIDE GAS ANALYZER
    Manufacturer
    VACUMED, DIV. OF VACUMETRICS, INC.
    Date Cleared
    1998-05-26

    (250 days)

    Product Code
    CCK
    Regulation Number
    868.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    VACUMED, DIV. OF VACUMETRICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Intended for measuring the concentration of carrbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status.
    Device Description
    Not Found
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    K Number
    K973545
    Device Name
    VACU*MED GOLD EDITION OXYGEN GAS ANALYZER
    Manufacturer
    VACUMED, DIV. OF VACUMETRICS, INC.
    Date Cleared
    1998-05-26

    (250 days)

    Product Code
    CCL
    Regulation Number
    868.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    VACUMED, DIV. OF VACUMETRICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The indications for use of the Gold Edition VacuMed Oxygen Gas Analyzer are to measure expired Oxygen Gases.
    Device Description
    The Vacumetrics Gold Edition Oxygen Gas Analyzer is a device that incorporates a Vacu. Med designed oxygen gas analyzer housing, with a commercially available oxygen paramagnetic gas analyzer (Servomex 1155B), a commercially available power supply (Condor), and other commercially available components to include a commercially available digital meter display which does not utilize any software.
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