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510(k) Data Aggregation

    K Number
    K231961
    Device Name
    NIBPCuff
    Manufacturer
    Shenzhen SINO-K Medical Technology Co.,Ltd
    Date Cleared
    2023-08-30

    (58 days)

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

    Shenzhen SINO-K Medical Technology Co.,Ltd

    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. 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, infant, child and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.
    Device Description
    The proposed device is an accessory used in conjunction with noninvasive blood pressure measurement systems. It is available in neonatal, infant, child and adult sizes. The proposed device includes disposable blood pressure cuff and reusable blood pressure cuff. Both disposable and reusable blood pressure cuff have the same structure, which contains Cuff with bladder and single-tube Air Hose.
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    K Number
    K223807
    Device Name
    Reusable Temperature Probe, Disposable Temperature Probe
    Manufacturer
    Shenzhen SINO-K Medical Technology Co.,Ltd
    Date Cleared
    2023-08-25

    (248 days)

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

    Shenzhen SINO-K Medical Technology Co.,Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Reusable Temperature Probes: Reusable Temperature Probes are intended to be used for monitoring temperature for multi- patient use. The temperature probes are reusable and designed for use with monitor of GE-Marquette Model DASH3000. These devices are used by qualified medical professionals only. Disposable Temperature Probes: Disposable Temperature Probes are intended to be used for monitoring temperature for single patient use. The temperature probes are non-sterile and designed for use with monitors of GE- Marquette Model DASH3000. These devices are used by qualified medical professionals only.
    Device Description
    The proposed devices are used for patient temperature measurement. The probes are reusable or disposable depending on the model. 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 increasing with temperature decrease, and the linear changes to the characteristics of the temperature measurement. The proposed devices are designed to be used in a healthcare facility and compatible with a monitor, GE-Marquette Model DASH3000. The six models have two types of structure designs corresponding to reusable and disposable use which consists of different materials. The Negative Temperature Coefficient (NTC) of the six models are identical. Reusable models ST1304, ST2304, ST3304, ST4304 have a similar structure design with two different sensor shapes for different measure sites and consist of the same materials. Disposable models ST5105A and ST6105A have a similar structure design with two different sensor shapes for different measure sites and consist of the same materials.
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