LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K100815
    Device Name
    OXIBLUE FINGERTIP PULSE OXIMETER MODEL MD300C318, OXIPRO FINGERTIP PULSE OXIMETER MODEL MD300C316
    Manufacturer
    OXYPULSE
    Date Cleared
    2010-06-16

    (85 days)

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

    OXYPULSE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The OxiBlue Fingertip Puls) Oximeter is indicated for continuous or spot-checking in measuring and displaying functional arterial overan saturation (SpO2) and pulse rate of patients in home care. It is intended for adu't and pediatric patients on finger between 0.3-1.0 inch (0.8 - 2.5 cm) thick. The OxiBlue can transmit in the either a USB cable or wireless Bluetooth technology. The OxiPro Fingertip Pulse Oximeter is indicated for continuous or spot-checking in measuring and displaying functional arter. V oxygen saturation (SpO2) and pulse rate of patients in home care. It is intended for adu' and pediatric patients on finger between 0.3-1.0 inch (0.8 - 2.5 cm) thick. The OxiPro can transmit Pro vio : USB cable, and does not include Bluetooth technology.
    Device Description
    Not Found
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1