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510(k) Data Aggregation

    K Number
    K092641
    Device Name
    CHARMCARE TABLETOP PULSE OXIMETER
    Manufacturer
    Date Cleared
    2010-10-21

    (420 days)

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

    CHARMCARE CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Charmcare Tabletop Pulse Oximeter is portable device indicated for use in non-invasively measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients via finger in hospitals, medical facilities, and subacute environments. Pediatric population in this 510(K) application is defined as 'infant' and 'child' which are ages from 1 month to 12 years according to the guidance 'Premarket Assessment of Pediatric Medical Devices' section IV. Charmcare Tabletop Pulse Oximeter is intended for spot-checking and / or continuous monitoring of patients, the sensor of device is reusable or disposable.
    Device Description
    The device works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660 nm, which is red light; the other is 940 nm, which is ultra red light. Skin, bone, tissue and venous vessels normally absorb a constant amount of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole into an oxygen saturation measurement. This measurement is referred to as SpO2. This applicant device of Accuro is the desktop pulse oximeter monitor, which mainly function are measurement, display, alarm, data storage.
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