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510(k) Data Aggregation

    K Number
    K243000
    Device Name
    Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)
    Date Cleared
    2025-06-20

    (267 days)

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

    Shenzhen Medke Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Temperature Probes are intended to be used for monitoring temperature. The temperature probes are reusable or for single patient use and designed for use with Mindray monitor Model PM-8000 and other monitors compatible with YSI 400 series temperature probes. These devices are used by qualified medical professional only.
    Device Description
    The subject devices are used for patient temperature measurement. The probes are reusable or disposable depending on models. These probes consist of a connector on the monitor end and a thermistor on the patient end. The working principle is resistance based on the metal conductor increases with temperature decrease, and the linear changes to the characteristics of the temperature measurement. The subject devices are designed to be used in healthcare facilities like hospital and compatible with a monitor of Mindray Model PM-8000 and other monitors compatible with YSI 400 series temperature probes. The six models have two types of structure designs corresponding to reusable and disposable use which consists of different materials. The NTC of the six models are identical. Reusable models T1306, T2306, T3306, T4306 have a similar structure design with two different sensor shapes for different measure sites and consist of the same materials. Disposable models T5106 and T6106 have a similar structure design with two different sensor shapes for different measure sites and consist of the same materials. Model: T1306, Description: Skin contact Temperature Probe, adult, reusable Model: T2306, Description: Body cavity Temperature Probe, Esophageal/Rectal, adult, reusable Model: T3306, Description: Skin contact Temperature Probe, pediatric, reusable Model: T4306, Description: Body cavity Temperature Probe, Esophageal/Rectal, pediatric, reusable Model: T5106, Description: Skin contact Temperature Probe, adult/ pediatric, disposable Model: T6106, Description: Body cavity Temperature Probe, Esophageal/Rectal, adult/ pediatric, disposable
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    K Number
    K242623
    Device Name
    Disposable Blood Pressure cuff; Reusable Blood Pressure cuff
    Date Cleared
    2024-10-31

    (58 days)

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

    Shenzhen Medke Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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. The cuff is not designed, sold, or intended for use except as indicated. The disposable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and for single-patient use. It is available in neonate size. The cuff is not designed, sold, or intended for use except as indicated.
    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. It is available in neonatal, infant, child and adult sizes. The subject device includes disposable blood pressure cuff and reusable blood pressure cuff and contains Cuff with/without bladder and single/dual tubes Air Hose.
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    K Number
    K152390
    Device Name
    Medke Oximetry Finger Sensor
    Date Cleared
    2016-08-18

    (360 days)

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

    Shenzhen Medke Technology Co., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Medke Oximetry Finger 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 40kg,
    Device Description
    The Medke Oximetry Finger Sensors are compatible sensor for use with major types of patient monitors and oximeter devices of Original Equipment Manufacturer (OEM). The sensors are made up of connector, cable, two specific wavelength LEDs & a photo detector assembled into the sensor housing. The sensors use optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter. The Medke Oximetry Finger Sensors contain finger clip type and soft tip type. The finger clip sensor is comprised of a plastic shell with silicone pads which position the optical components, and a cable with OEM compatible connector. The soft finger sensor consists of an integrated silicone rubber tip which is installed the optical components, and a cable with OEM compatible connector. The Medke Oximetry Finger Sensors have unique labeling and specifications designed for compatibility with Nellcor patient monitor(NPB40) cleared in K963707.
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