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510(k) Data Aggregation

    K Number
    K062724
    Device Name
    ACCUPULSE PULSE OXIMETER
    Date Cleared
    2007-05-11

    (241 days)

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

    EAGLE MEDICAL EQUIPMENT CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Finger Pulse Oximeter is a small portable device that measures % SpO2, pulse rate, and pulse indication on the finger. It may be used as a spot-check device in the home or clinical environment. The pulse oximeter will provide reliable measurements on pediatric patients weighing 35 lbs or more, and on adult patients. This device is not intended for continuous patient monitoring. There are no audible or visible patient alarms.
    Device Description
    The AccuPulse Oximeter is a portable, lightweight, and battery-operated device that measures %SpO2 and pulse rate on the finger of a patient.
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    K Number
    K955129
    Device Name
    OXYPULSE EOC I, EOC II & EOC R
    Date Cleared
    1996-02-16

    (99 days)

    Product Code
    Regulation Number
    868.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    EAGLE MEDICAL EQUIPMENT CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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