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510(k) Data Aggregation

    K Number
    K071642
    Device Name
    MEDIAID M960 SERIES, VITAL SIGNS MONITOR AND MEDIAID M900 SERIES, PULSE OXIMETER
    Manufacturer
    MEDIAID INC.
    Date Cleared
    2008-05-02

    (319 days)

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

    MEDIAID INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Model 960 Series is a desktop monitor intended for use as a continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, non invasive blood pressure and temperature. The intended patient population comprises adult, and pediatric weighing more than 5Kg. The intended environment of use is hospital environment. Hospital use typically covers areas such as general care floors, operating rooms, special procedure areas, intensive and critical care areas within the hospital plus hospital-type facilities such as surgical centers, sub-acute centers, special nursing facilities and sleep labs. The Model 900 is an Pulse Oximeter only. WARNING: The Model 900 and 960 Series is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms.
    Device Description
    The Mediaid Vital Signs monitor Pulse Oximeter Model M960P provides real time monitoring and display of ox vgen saturation of arteriolar hemoglobin (SpO2), Non Invasive Blood Pressure, pulse rate and body temperature. Where as the Mediaid Pulse Oximeter Model M900 provides real time monitoring and display of oxygen saturation of arteriolar hemoglobin (SpO2) and pulse rate only. Noninvasive arterial oxygen saturation measurement is obtained by directing red and infra red light through a pulsating vascular bed. The pulsating arterioles in the path of the light beam cause a change in the amount of light detected by a photodiode. The pulse oximeter determines the oxygen saturation of arterial blood by measuring the ratio of transmitted red to infrared light within the pulse waveform. The non-pulsatile signal is removed electronically for the purpose of calculation. Therefore, skin, bone, and other non-pulsating substances do not interfere with the measurement of arterial oxygen saturation. Non invasive blood pressure is intended to non invasively measure systolic, diastolic and mean arterial pressures (MAP). Temperature- Thermometer takes patient temperature in oral, axillary or rectal mode.
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    K Number
    K071610
    Device Name
    MEDIAID PULSE OXIMETER M30 AND M34
    Manufacturer
    MEDIAID INC.
    Date Cleared
    2007-11-05

    (145 days)

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

    MEDIAID INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Non-invasive measurement of arterial oxygen saturation and pulse rate in hospitals, physician's office, emergency medical facilities, or at home. The model 34 can store data in memory for later review and documentation and also features a sleep mode for basic patient sleep screening.
    Device Description
    The Mediaid Pulse Oximeter Model 34 is designed to measure the percentage of functional oxygenated hemoglobin to total hemoglobin. Noninvasive arterial oxygen saturation measurement is obtained by directing red and infra red light through a pulsating vascular bed. The pulsating arterioles in the path of the light beam cause a change in the amount of light detected by a photodiode. The pulse oximeter determines the oxygen saturation of arterial blood by measuring the ratio of transmitted red to infrared light within the pulse waveform. The non-pulsatile signal is removed electronically for the purpose of calculation. Therefore, skin, bone, and other non-pulsating substances do not interfere with the measurement of arterial oxygen saturation.
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    K Number
    K061896
    Device Name
    MEDIAID DISPOSABLE NON-ADHESIVE SENSORS, MODEL CST050-2101N; REUSABLE FINGER CLIP SP02 SENSORS, MODEL CST060-2101N
    Manufacturer
    MEDIAID INC.
    Date Cleared
    2007-04-12

    (283 days)

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

    MEDIAID INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Mediaid's compatible sensors are indicated as accessories to pulse oximeters used on Pulse Oximeters manufactured by Nonin Inc for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in infant, pediatric, and adult patients.
    Device Description
    Mediaid SpO2 sensors are electro-optical sensors that function without skin penetration, electrical contact, or heat transfer. The sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter. The sensor contains three optical components: two light emitting diodes (LED) that serve as light sources and one photodiode that acts as a light detector. The optical components are housed in adhesive film, rigid spring-loaded clip, or foam and Velcro wrap. The sensor cable is terminated in a DB-9 connector.
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    K Number
    K041964
    Device Name
    MEDIAID REUSABLE FINGER CLIP SPO2 SENSORS AND DISPOSABLE NON-ADHESIVE SENSORS AND ADHESIVE SPO2 SENSORS
    Manufacturer
    MEDIAID INC.
    Date Cleared
    2004-09-14

    (55 days)

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

    MEDIAID INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mediaid SpO2 Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring.
    Device Description
    Mediaid SpO2 sensors are electro-optical sensors that function without skin penetration, electrical contact, or heat transfer. The sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter. The sensor contains three optical components: two light emitting diodes (LED) that serve as light sources and one photodiode that acts as a light detector. The optical components are housed in adhesive film, rigid spring-loaded clip, or foam and Velcro wrap. The sensor cable is terminated in a DB-9 style connector, with an adapter cable for Datex-compatible models.
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