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V9 Patient Monitor is intended to be used for monitoring, displaying, storing and alarming of multiple physiological parameters of patients, including Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Carbon dioxide (CO2) and Temperature (Temp). V9 Patient Monitor is used to monitor vital signals for patients and is intended to be used in controlled, hospital environments. It is applicable for adult, pediatric and neonatal patiented for helicopter transport, hospital ambulance or home use.

The V9 Patient Monitor can provide the monitoring of physiological parameters such as the Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Carbon dioxide (CO2) and Temperature (Temp). The V9 Patient Monitor is a portable device, consists of main unit and accessories, including NIBP cuff, Temperature sensor, CO2 sensor and SpO2 sensor. It consists of main unit and accessories, including NIBP cuff, Temperature sensor, CO2 sensor and SpO2 sensor. All modules, boards and accessories used in V9 Patient Monitor has already been cleared by FDA, referring to Table 1. In which, two NIBP and three SpO2 modules are optional for proposed device.

Central Monitoring System Software is intended to conduct centralized monitoring of adult, pediatrics and neonatal patient's vital sign information from compatible bedside monitors. The software collects, stores, displays and alarms the information provided on the bedside monitoring parameters include Electrocardiogram(ECG), Heart Rate(HR), Respiration(RESP), Pulse Oxygen Saturation(SpO2), Pulse Rate(PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure(IBP), Impedance Cardiograph(ICG), TEMP(Temperature), Carbon dioxide (CO2), Anesthetic Gas (AG), Fetal Heart Rate (FHR), Uterine contraction (TOCO) and Fetal Movement (FM) etc. It is intended to be used in the hospital or medical institutions, and it is not intended for home use.

M6000C central monitoring system software, the risk management object, can central monitor significant vital sign parameters of multi-patients, including ECG/HR, RESP, SpO2, PULSE, NIBP, IBP, ICG, TEMP, CO2, AG, FHR, TOCO and FM. It is connected by network with bedside units and receives data from bedside units. Then, the data are displayed on the screen or recorded or printed as per needs. When the monitored data exceed a set value, the central monitoring system software will start alarm system and gives out alarm to remind doctors and nurses for attention.

Truscope Ultra Patient monitors are intended to be used for monitoring, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead selectable), arrhythmia detection, ST segment analysis, Heart Rate (HR), Respiration Rate (RESP), Temperature (TEMP), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Carbon dioxide (CO2), Anesthetic Gas (AG), Impedance Cardiograph (ICG), Cerebral Index (CSI), Bispectral Index (BIS), Total Hemoglobin(SpHb), Carboxyhemoglobin (SpCO), Methemoglobin(SpMet). The arrhythmia detection. ST segment analysis only applied to a single adult patient. The monitors are to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physician. It is not intended for helicopter transport, hospital ambulance, or home use.

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The device is intended to measure diastolic, systolic blood pressure and the pulse rate of an adult patient via non-invasive technique in which an inflatable cuff is wrapped around the upper arm. It is intended to be used at home. The intended arm circumference is 17cm~22cm, 22cm~32cm, 32cm~42cm.

The subject device is a battery driven automatic on-invasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure and the pulse rate of adult at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or KPa. All the models included in this submission follow the same software, same measurement principle and same specifications. The WBP100 does not have LCD display but has Bluetooth; WBP201 does not have Bluetooth but has LCD display, and WBP202 has LCD display and Bluetooth. The difference will not affect the safety and effectiveness of the subject device.

Central Monitoring System Software is intended to conduct centralized antepartum and intrapartum monitoring of pregnant women's vital sign information from compatible bedside monitors. The software collects, stores, displays and alarms the information provided on the bedside monitor. The monitoring parameters include Electrocardiogram(ECG), Heart Rate(HR), Respiration(RESP), Pulse Oxygen Saturation(SpO2), Pulse Rate(PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure(IBP), Impedance Cardiograph(ICG), TEMP(Temperature), Carbon dioxide (CO2), Anesthetic Gas (AG), Fetal Heart Rate (FHR), Uterine contraction (TOCO) and Fetal Movement (FM). It is intended to be used in the hospital or medical institutions, and it is not intended for home use.

The Central Monitoring System Software-only device that is intended to conduct centralized antepartum and intrapartum monitoring of pregnant women's vital sign information from compatible bedside monitors connected by a wired or wireless network. The Central Monitoring System consists of two models: M6000C and Truscope CNS. Both models provide functions including collecting, storing, displaying, and alarming (e.g. when the monitored data exceeds a set value, the device will alarm to alert medical personnel) the information which is received from the bedside monitor(s). Multiple patients can be monitored simultaneously. Parameters monitored include ECG/HR, RESP, SpO2, PULSE, NIBP, IBP, ICG, TEMP, CO2, AG, FHR, TOCO and FM.

The vital signs monitor is intended to be used for monitoring, reviewing, storing and alarming of multiple physiological parameters of patients, including Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Carbon dioxide (CO2) and Temperature (Temp). This vital signs monitor is used to monitor vital signals for use in hospital environments including out-patient department, wards and NICU. It is not intended for helicopter transport, hospital ambulance or home use. And it is applicable for adult, pediatric and neonatal patients.

The Vital Signs Monitor is a portable device intended for use by health care professionals. The monitor could provide the monitoring of physiological parameters such as the Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Carbon dioxide (CO2) and Temperature (Temp). The following lists the detailed features of the subject device. - LCD/LED display - SpO2, Pulse Rate NIBPCO2 and TEMP measurement - Infrared ear temp or fast temp module for Temp measurement - Nellcor or Masimo or BLT SpO2 module - Display numeric and waveform information simultaneously . - Nurse call feature - . Built-in Lithium-ion Battery - Suitable for adult, pediatric and neonate patients . - Visual and audible alarm

The Fingertip Pulse Oximeter is intended to measure functional arterial oxygen saturation (SpO2) and pulse rate of adult, child and adolescent patients in hospital, hospital type facilities, as well as in the home care environment. The oximeter is not suitable to monitor patient continuously for long term.

The proposed devices, Fingertip Pulse Oximeters M70, M70A, M70C and M70D are fingertip devices, which can display %SpO3, pulse rate value, waveform pulse amplitude bar indication. The five models share the same configuration, intended use, safety and performance, the only difference is extrinsic feature. The proposed devices, Fingertip Pulse Oximeters M70, M70A, M70C and M70D are modified versions of the predicate device, M70, cleared under K081712. The oximetry technology including the sensor was unchanged.

Digital Electrocardiographs are intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.

Digital Electrocardiographs, E30, E65, E70 and E80, are intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. There is no specific contraindication identified for the proposed devices. The proposed devices acquire ECG electrical signals from patient body surface by ECG electrodes. After been amplified, filtered and transferred, the ECG signal waveforms are displayed on the LCD and recorded on the paper through thermal printer. The components of the proposed devices, Digital Electrocardiograph, include: (1) chest electrodes (2) limb electrodes, (3) cable and (4) Batteries;

M800 handheld monitor is intended for continuously monitoring or spot checking of SpO2, PR, ECG and HR of adult, pediatric and neonatal patients in hospital type facilities as well as in the home care environment.

The proposed device, M800 is a handheld patient monitor for continuously monitoring and spot checking of SpO2, PR, ECG and HR of adult, pediatric and neonatal patients. The proposed device includes three display modes for monitoring results, data review function, and audio and visual alarming function. It consists of four functional modules, which are power supply module, parameter measurement module, main control and human-device interface.

Patient monitors are intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead or 12-lead selectable), arrhythmia detection, ST segment analysis, Heart Rate (HR), Respiration Rate (RESP), Temperature (TEMP), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Carbon dioxide (CO2), Anesthetic Gas (AG), Impedance Cardiograph (ICG), Cerebral State Index (CSI), Bispectral Index (BIS), Total Hemoglobin(SpHb), Carboxyhemoglobin (SpCO), and Methemoglobin(SpMet). The arrhythmia detection, ST segment analysis only applied to a single adult patient. The monitors are to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physician. It is not intended for helicopter transport, hospital ambulance, or home use.

The Patient Monitors consist of two parts, which are host units and function modules. The host units of Any View A Series Patient Monitors are available in four modules, which are Any View A3, AnyView A5, Any View A6 and AnyView A8, The units, themselves, did NOT collect any physiological data from the patient, which are collected by function modules and transmitted to the host unit. They shall be worked with the basic function module, EMS or MPS. The host units of Q Series Patient Monitors are available in six modules, which are Q2, Q3, Q6 and Q7. These host units could complete the measurement of ECG, RESP, TEMP, SpO2, NIBP and IBP. In addition, there are several extended function modules, which could be connected with the host units to complete the measurement functions, including TEMP, CO2 Mainstream, CO2 Sidestream, SpO2 Nellcor, SpO2 Masimo, AG Mainstream, AG Sidestream, ICG and CSM (CSI).