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510(k) Data Aggregation

    K Number
    K023820
    Device Name
    CO2 CLIP
    Manufacturer
    BREGAS AB
    Date Cleared
    2003-05-07

    (173 days)

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

    BREGAS AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of BreGas AB CO2 Clip Indicator is to provide a semi-quantitative visualization of the CO2 in the patient airway or in the gas exhaled from a patient. It is an adjunct in patient assessment, to be used in conjunction with other methods to determine clinical signs and symptoms by or on the order of a physician.
    Device Description
    Not Found
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    K Number
    K000520
    Device Name
    C-IT
    Manufacturer
    BREGAS AB
    Date Cleared
    2000-05-16

    (90 days)

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

    BREGAS AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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