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510(k) Data Aggregation

    K Number
    K182327
    Device Name
    Patient Cables and Leadwires , Disposable ECG Leadwires
    Manufacturer
    Orantech Inc.
    Date Cleared
    2019-01-30

    (156 days)

    Product Code
    DSA
    Regulation Number
    870.2900
    Why did this record match?
    Applicant Name (Manufacturer) :

    Orantech Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended to be used with ECG. The lead wire is used to connect electrodes placed at appropriate sites on the patient to ECG for general monitoring and/or diagnostic evaluation by health care professional.
    Device Description
    The device is used to transmit ECG signals from electrodes which are affixed to the patient's body for both diagnostic and monitoring purposes. Each lead wire is attached to ECG patient electrodes. The lead wire connector plugs into one end of the trunk cable which are plug into an ECG monitor. The proposed devices are available in disposable and reusable two types.
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    K Number
    K173194
    Device Name
    Temperature Probe
    Manufacturer
    Orantech Inc.
    Date Cleared
    2018-10-10

    (373 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    Orantech Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Orantech Temperature Probes are intended to be used for monitoring temperature. The temperature probes are reusable and designed for use with monitors of Philips Model MP30 and Nihon Kohden Model BSM-6301A. These devices are indicated for used by qualified medical personnel only.
    Device Description
    Reusable temperature probes are used during patient temperature measurement for multi-patient use. These probes consist of a phone plug connector on the monitor end and a thermistor on the patient end. Temperature probes measure temperature by a resistor that is sensitive to temperature changes. These probes are connected to the patient monitor either directly by using a phono plug or by an interconnect cable. These probes have a skin or core contact with a patient. These temperature probes are typically used with legacy Philips monitor model MP30 and Nihon Kohden monitor model BSM-6301A.
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    K Number
    K181270
    Device Name
    Disposable SpO2 Sensors, Reusable SpO2 Sensors
    Manufacturer
    Orantech Inc.
    Date Cleared
    2018-09-07

    (116 days)

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

    Orantech Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable and Reusable SPO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult patients weighing greater than 40 kg at hospital facilities.
    Device Description
    The proposed device, Disposable and Reusable SpO2 Sensors are accessories to the oximeters, which are intended for spot checking or continuous monitoring of functional arterial oxygen saturation and pulse rate in non-invasive with U.S. legally marketed oximeters or patient monitors. The SSD-001-W09AN sensors is disposable while the SS-010-AF10 and SS-018-AF10 sensors are reusable. They are only intended for adult. The sensor shall be connected with its corresponding monitor. Oxygenation of blood is measured by detecting the infrared and red light absorption characteristics of deoxygenated hemoglobin and oxygenated hemoglobin, which consists of a probe attached to the patient's finger. The sensor is connected to a data acquisition system which is used to calculate and display oxygen saturation levels and heart rate conditions. Each sensor has two LEDs, emitting both red and infrared light, and a photodiode. Red and infrared light lit alternately according to certain sequence, when the fingertips of capillary repeatedly with the heart pumps blood congestion, light emitting diode after blood vessels and projected onto a photodiode, photodiode can be induced to change with pulse light intensity, the electrical signals in the form of change. Then the received signal is forwarded to the corresponding oximeter that amplifies the signal and an algorithm that calculates the ratio. By measuring the wave crest of the pulse wave and the absorbance of the trough, SpO2 is calculated to obtain the correct oxygen saturation value. The saturation value is determined by the percentage ratio of the oxygenated hemoglobin (HbO2) to the total amount of hemoglobin (Hb).
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    K Number
    K173197
    Device Name
    Reusable NIBP Cuff
    Manufacturer
    Orantech Inc.
    Date Cleared
    2018-08-21

    (323 days)

    Product Code
    DXQ, DXO
    Regulation Number
    870.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    Orantech Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The reusable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and may be reused. It is available in neonate, infant, child and adult sizes.
    Device Description
    The device comprises tubing attached to an inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure. The device tubing is connected to a non-invasive blood pressure measurement system. The reusable NIBP cuff has 9 models with different size for different population with different arm size.
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    K Number
    K171828
    Device Name
    ETCO2 Sensor
    Manufacturer
    Orantech Inc.
    Date Cleared
    2018-05-31

    (345 days)

    Product Code
    CCK
    Regulation Number
    868.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Orantech Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the ETCO2 sensor is to provide carbon dioxide monitoring to a host monitoring system during anesthesia / recovery, in the intensive care unit (ICU), and in Emergency Medicine/Transport or Respiratory care.
    Device Description
    The ETCO2 Sensor is comprised of three main components, a sensor with photo detector and light emitter, cable and connector, The CO2 Sensor incorporates an infrared light source, of specified wavelength, and an infrared detector. The photo detector and light emitter end of the CO2 sensor is connected to an airway adapter. The airway adapter is connected between the patient airway and the respirator. As the patient completes an expiratory breath the sensor measures the CO2 levels in the expiratory breath and sends that data to the compatible CO2 monitor. The monitor then reads the data and converts the data so it can be displayed on screen.
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