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510(k) Data Aggregation

    K Number
    K053419
    Device Name
    KONICA MINOLTA PULSOX-300, 300I
    Manufacturer
    KONICA MINOLTA SENSING, INC.
    Date Cleared
    2006-05-11

    (154 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    KONICA MINOLTA SENSING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Konica Minolta Models PULSOX-300 and PULSOX-300i are devices designed for non-invasive measurement of the oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate from light signals of two wavelengths transmitted through tissues of adult patients who have pulmonary disease, pulmonary dysfunction, or who need sleep study.
    Device Description
    The Konica Minolta Models PULSOX-300 and PULSOX-300i are devices designed for non-invasive measurement of the oxygen saturation of arterial hemogliobin (SpO2) and pulse rate from light signals of two wavelengths transmitted through tissues of adult patients who have pulmonary disease, pulmonary dysfunction, or who need sleep study. SpO2 is, as defined in ISO 9919:2005, percent of hemoglobin saturation with oxygen measured by a pulse oximer and displayed as a percentage. The measurement principle depends on a changing signal caused by the pulsatile nature of blood flow.
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    K Number
    K021469
    Device Name
    MINOLTA PULSOX-2
    Manufacturer
    KONICA MINOLTA SENSING, INC.
    Date Cleared
    2003-02-12

    (281 days)

    Product Code
    DQA, DOA
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    KONICA MINOLTA SENSING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Minolta PULSOX-2 is indicated for the non-invasive monitoring of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The Minolta PULSOX-2 is intended for use with adult patients. The Minolta PULSOX-2 is for spot-checking only.
    Device Description
    The Minolta PULSOX-2, is the device for determination of saturation of hemoglobin (SpO2) non-invasively from light signals of two wavelengths transmitted through from tissues of patients who have pulmonary disease or pulmonary dysfunction. SpO2 is, as defined in 1.3.14 of ISO 9919:1992, percent of hemoglobin saturation with oxygen measured by a pulse oximeter and displayed as a percentage. The measurement principle depends on a changing signal caused by the pulsatile nature of blood flow.
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    K Number
    K010413
    Device Name
    MINOLTA PULSOX-3SI, PULSOX-3IA, PULSOX-3LI
    Manufacturer
    KONICA MINOLTA SENSING, INC.
    Date Cleared
    2001-08-02

    (171 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    KONICA MINOLTA SENSING, INC.

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

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