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510(k) Data Aggregation

    K Number
    K990648
    Device Name
    KELLER VITAL SIGNS MONITOR, KMS 890+
    Manufacturer
    KELLER MEDICAL SPECIALTIES PRODUCTS, INC.
    Date Cleared
    1999-08-10

    (162 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    KELLER MEDICAL SPECIALTIES PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Keller Medical Specialties Model-KMS890+ Combined Pulse Oximeter and Non-invasive Blood Pressure Monitor is intended to monitor the arterial oxygen saturation (SaO2), pulse rate and measure the blood pressure parameters. All values are obtained by non-invasive methods. The blood pressure parameters measured are systolic and mean arterial pressure. This device can be operated by the internal rechargeable battery. Alarm settings for the displayed parameters can be adjusted as required.
    Device Description
    The Model KMS-890+ is a portable, battery operated, non-invasive monitor used to measure a patient's blood pressure and/or oxygen saturation level with the pulse rate
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    K Number
    K982331
    Device Name
    KELLER PULSE OXIMETER, MODEL 850+
    Manufacturer
    KELLER MEDICAL SPECIALTIES PRODUCTS, INC.
    Date Cleared
    1998-09-11

    (71 days)

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

    KELLER MEDICAL SPECIALTIES PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Keller Medical Specialties Pulse Oximeter Model 850+ measures and monitors arterial oxygen saturation (SaO2) and pulse rate using standard dual wavelength pulse oximetry techniques. This unit is portable with battery operation. The oximeter allows complete control of patient alarm limit settings. This unit is not intended for use on neonates.
    Device Description
    The Keller Model 850+ Pulse Oximeter is a portable, battery operated, patient pulse oximeter. It measures oxygen saturation and the pulse rate of the patient by means of an infrared sensor attached to the finger or ear.
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