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510(k) Data Aggregation

    K Number
    K042675
    Device Name
    FLEXI-STAT SP02 EAR SENSOR
    Manufacturer
    ELEKON INDUSTRIES U.S.A., INC.
    Date Cleared
    2004-12-06

    (68 days)

    Product Code
    DPZ
    Regulation Number
    870.2710
    Why did this record match?
    Product Code :

    DPZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing >10 kg
    Device Description
    The Flexi-Stat(tm) SpO2 Sensor is an electro-optical sensor that functions 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 a durable ear clip housing. The sensor cable is terminated in a DB-9 style connector.
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    K Number
    K040831
    Device Name
    DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500
    Manufacturer
    DATEX-OHMEDA, INC.
    Date Cleared
    2004-09-02

    (155 days)

    Product Code
    DPZ
    Regulation Number
    870.2710
    Why did this record match?
    Product Code :

    DPZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Datex-Ohmeda TruSat Pulse Oximeter and Accessories is indicated for spotchecking and continuous monitoring of functional oxygen saturation and pulse rate, including monitoring during conditions of clinical patient motion or low perfusion. These devices are intended for use with adult, pediatric and neonatal patients in both hospital and non-hospital environments.
    Device Description
    The TruSat is the next generation in the Datex-Ohmeda Pulse Oximeter family of products. The Datex-Ohmeda 3800 Series and 3900 Series Pulse Oximeters and Accessories with TruTrak Plus Enhancements and the Datex-Ohmeda TruSat Pulse Oximeter and Accessories are substantially equivalent in design concepts, technologies and materials. The TruSat was validated through rigorous testing that, in part, support the compliance of the TruSat to the above mentioned standards. Additionally, the software for the TruSat was developed following a robust software development process and was fully specified and validated.
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    K Number
    K012333
    Device Name
    FLEXI-SITE SP02 EAR SENSOR
    Manufacturer
    EPIC MEDICAL EQUIPMENT SERVICES, INC.
    Date Cleared
    2001-10-17

    (85 days)

    Product Code
    DPZ
    Regulation Number
    870.2710
    Why did this record match?
    Product Code :

    DPZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Flexi-Site SpO2 Ear Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing > 30 kg.
    Device Description
    The Flexi-Site SpO2 Sensor is an electro-optical sensor that functions 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 a durable silicone casing. The sensor cable is terminated in a Hypertronics style connector.
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    K Number
    K010718
    Device Name
    FLEXI-SITE SP02 EAR SENSOR
    Manufacturer
    EPIC MEDICAL EQUIPMENT SERVICES, INC.
    Date Cleared
    2001-03-23

    (11 days)

    Product Code
    DPZ
    Regulation Number
    870.2710
    Why did this record match?
    Product Code :

    DPZ

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