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510(k) Data Aggregation

    K Number
    K180837
    Device Name
    CONTEC Oxygen Concentrator
    Manufacturer
    Contec Medical System Co., Ltd.
    Date Cleared
    2019-01-10

    (286 days)

    Product Code
    CAW
    Regulation Number
    868.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    Contec Medical System Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CONTEC™ Oxygen Concentrator, OC3D, is intended to provide supplemental oxygen in a home, institutional environment. The device is only used for adult and prescription use only.
    Device Description
    The Oxygen Concentrator is a small and portable oxygen concentrator. It consisted of air compressor, adsorption tower of molecular sieve, oxygen sensor and flow meter. It adopts pressure swing absorbers(PSA) directly concentrate the medical oxygen from the air. The machine takes the advantages of small in volume, light in weight, convenient in moving (as it has turning truckle), stable in performance, easy in operating, low in noise, which complies with requirements of medical device. The OC3D is divided into power module, MCU control module, Pressure detection module, Oxygen concentration detection module, alarm module, Compressor and fan drive module, Solenoid valve drive module, Display driver module, Work indication module, button detection module.
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    K Number
    K131900
    Device Name
    CONTEC ELECTROCARDIOGRAPH
    Manufacturer
    CONTEC MEDICAL SYSTEM CO., LTD.
    Date Cleared
    2014-03-05

    (253 days)

    Product Code
    DPS
    Regulation Number
    870.2340
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONTEC MEDICAL SYSTEM CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CONTECTM Electrocardiographs, ECG100G/ECG300G/ECG1200G, are intended to acquire ECG signals from adult 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.
    Device Description
    The proposed device, CONTECTM Electrocardiograph, has three models: ECG100G, ECG300G and ECG1200G. The three models all have three design modules, which are power module, signal acquisition and processing module and control module. The proposed devices acquire ECG signal via twelve leads simultaneously, display or print waveform of ECG signal via single channel/ three channel/ twelve channel. The proposed device, model ECG100G, has two recording modes, including automatic mode and manual mode; the other two models, ECG300G and ECG1200G have three recording modes, including automatic mode, manual mode and rhythm mode. The proposed devices are designed to acquire, process, display and record ECG signals from patient body surface by ECG electrodes. After been amplified and filtered, the ECG signal waveforms are displayed on the LCD screen and recorded on the paper through thermal printer. ECG data, waveform and patient information could be stored in the memory of the device;
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    K Number
    K101273
    Device Name
    DYNAMIC ECG SYSTEM MODEL TLC5000
    Manufacturer
    CONTEC MEDICAL SYSTEM CO., LTD.
    Date Cleared
    2011-09-30

    (512 days)

    Product Code
    MLO, MLQ
    Regulation Number
    870.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONTEC MEDICAL SYSTEM CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dynamic ECG System, TLC5000, is intended to continuously acquire ambulatory ECG data for up to twelve leads. It can record the ECG data for at most twenty four hours. The ECG data obtained will be stored in the recorder first and then download to PC for analysis, reviewing and printing by a trained physician in health facilities.
    Device Description
    Dynamic ECG System, TLC5000, mainly consists of two parts: a recorder, analysis software and accessories. The recorder is designed to acquire, display and record ECG signals from patient body surface by ECG electrodes. After been amplified, filtered and analyzed, the ECG signals waveforms, as well as the patient information will be displayed and stored in the memory of the recorder. The information stored can be downloaded to PC; the ECG signal then can be analyzed by the analysis software. The analysis results are only used as advisory basis. The accessories contain disposable electrodes, cables, USB connecting line.
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    K Number
    K110156
    Device Name
    AMBULATORY BLLOD PRESSURE MONITOR, ELECTRONIC SPHYGMOMANOMETER,
    Manufacturer
    CONTEC MEDICAL SYSTEM CO., LTD.
    Date Cleared
    2011-07-27

    (189 days)

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

    CONTEC MEDICAL SYSTEM CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ABPM50 Automatic Blood Pressure Monitor is intended to monitor the systolic, diastolic and mean blood pressure as well as pulse rate via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used on adult, pediatric and neonatal individuals.
    Device Description
    The proposed device, ABPM50 Automatic Blood Pressure Monitor, is battery driven automatic non-invasive Blood Pressure Monitor. It can automatically complete the inflation and BP measurement, which can measure systolic, diastolic and mean blood pressure as well as the pulse rate at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or kPa. ABPM50 can be used on adult, pediatric, and neonatal individuals. The device has the data storage function for data review including measurement time, systolic blood pressure, diastolic blood pressure, mean blood pressure and pulse rate. These records can be uploaded to PC via USB and processed with the PC software. ABPM50 has physiological alarm function which can be turned on or off by users. When the measurement results exceed the alarm limit, the physiological alarm function will be triggered. The alarm limit can be set by users, and the low limit must be lower than the corresponding high limit. In addition, it has technical alarm function which will be triggered when the battery voltage is lower than 2.3V , and this alarm can not be cancelled unless being closed or the power replaced.
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    K Number
    K101692
    Device Name
    PATIENT MONITOR
    Manufacturer
    CONTEC MEDICAL SYSTEM CO., LTD.
    Date Cleared
    2011-06-28

    (377 days)

    Product Code
    MHX, BZQ, CCK, DQA, DRT, DSI, DSK, DXN, FLL, MLD
    Regulation Number
    870.1025
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONTEC MEDICAL SYSTEM CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CMS8000 Patient Monitor is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG, Heart Rate (HR), Respiration Rate (RESP), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), carbon dioxide (CO2), and Temperature (TEMP) of adult, pediatric and neonatal patient. The Pulse Oxygen Saturation (SpO2) and Pulse Rate (PR) are intended use for adult and pediatric patient. The monitor is to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. It is not intended for helicopter transport or hospital ambulance.
    Device Description
    The proposed device, CMS8000 Patient Monitor is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters. It has the physical and technical alarming function with audio and visual alarming, The device can driven by AC or DC power supply.
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    K Number
    K110774
    Device Name
    ELECTRONIC SPHYGMOMANOMETER
    Manufacturer
    CONTEC MEDICAL SYSTEM CO., LTD.
    Date Cleared
    2011-05-13

    (53 days)

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

    CONTEC MEDICAL SYSTEM CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CONTEC08A Electronic Sphygmomanometer is intended to measure the systolic, diastolic and mean blood pressure as well as pulse rate via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used on adult, pediatric and neonatal individuals.
    Device Description
    The proposed device, CONTEC08A Electronic Sphygmomanometer is battery driven automatic non-invasive Blood Pressure Monitor. It can automatically complete the inflation, deflation and BP measurement, which can measure systolic, diastolic and mean blood pressure as well as the pulse rate at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or kPa. The device can be used on adult, pediatric, and neonatal individuals. The device has the data storage function for data review including measurement time, systolic blood pressure, diastolic blood pressure, mean blood pressure and pulse rate. These records can be uploaded to PC via USB and processed with the PC software. CONTEC08A has physiological alarm function which can be turned on or off by users. When the measurement results exceed the alarm limit, the physiological alarm function will be triggered. The alarm limit can be set by users, and the low limit must be lower than the corresponding high limit. In addition, the device has technical alarm function which will be triggered when the battery voltage is lower than 3.9V, and this alarm can not be cancelled unless being closed or the power replaced.
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    K Number
    K101127
    Device Name
    PATIENT MONITOR, MODEL PM50
    Manufacturer
    CONTEC MEDICAL SYSTEM CO., LTD.
    Date Cleared
    2010-06-11

    (50 days)

    Product Code
    MWI
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONTEC MEDICAL SYSTEM CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The patient monitor is a portable device indicated for use in non-invasively measuring and displaying functional oxygen saturation of arterial haemoglobin (SpO2), pulse rate(PR), Non-invasive measurement of blood pressure(NIBP) of adult patients in hospitals, medical facilities, and sub-acute environments. The patient monitor is intended for spot-checking and/or continuous monitoring of patients.
    Device Description
    The proposed device, PM50 Patient Monitor, is a portable device, which is intended for measuring and/or cont pulse oxygen saturation (SpO2), pulse rate (PR), systolic pressure (SYS), diastolic pressure (DIA) and mean arterial pressure (MAP) on adult and pediatric.
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    K Number
    K090936
    Device Name
    SINGLE-CHANNEL HANDHELD ELECTROCARDIOGRAPH, MODEL ECG80A
    Manufacturer
    CONTEC MEDICAL SYSTEM CO., LTD.
    Date Cleared
    2009-08-25

    (145 days)

    Product Code
    DPS, REG
    Regulation Number
    870.2340
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONTEC MEDICAL SYSTEM CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ECG80A Single-Channel Handheld Electrocardiograph is intended for use in non-invasive recording and displaying ECG waveform of adult patients. In addition, it also can provide to the treating physician with relevant data on the cardiac rhythm in hospital patients. It is immediately available at any time to manually record transient cardiac events, suitable for patient and professional use, helpful in determining the cardiac rhythm at the time of symptoms. This device allows the patient to record their ECG data for displaying or print on the paper. The product is not a conventional diagnostic tool.
    Device Description
    This product is single channel, standard 12 leads electrocardiograph ,can be widely applied in ECG check-up under different circumstances such as in family ,hospital consultation, doctor's diagnosis, physical check-up, social medical organizations etc. it can implement real time continuous records of clear and exact single-channel ECG waveform using thermo sensitive printer at the same time. waveforms also can be freezed at any time. it has manual and automatic modes to be chosen and Chinese/English operation interface, it is easy to be used.
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    K Number
    K090671
    Device Name
    PULSE OXIMETER, MODELS CMS50E, CMS50F, CMS60C, CMS60D
    Manufacturer
    CONTEC MEDICAL SYSTEM CO., LTD.
    Date Cleared
    2009-06-11

    (90 days)

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

    CONTEC MEDICAL SYSTEM CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pulse Oximeter is a non-invasive device intended for the spot-check or continuously monitor of oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate of adult patients through finger in home and hospital environments (including clinical use in internist/surgery, anesthesia, intensive care etc.). The device is not intended for single use and out-of-hospital transport use.
    Device Description
    The Fingertip Pulse Oximeter is tiny, and with low power consumption, convenient to use and carry. You just need to put the fingertip into the sensor of the device, the SpO2 value will appear on the screen immediately.
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    K Number
    K082480
    Device Name
    CONTEC POCKET FETAL DOPPLER
    Manufacturer
    CONTEC MEDICAL SYSTEM CO., LTD.
    Date Cleared
    2009-02-25

    (181 days)

    Product Code
    KNG
    Regulation Number
    884.2660
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONTEC MEDICAL SYSTEM CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Contect Pocket Fetal Doppler (SONOLINE A, SONOLINE B, Baby Sound A and Baby Sound B) are hand-held, battery powered audio Doppler devices used for detecting fetal heart beats. They are all available for user replaceable batteries. The user interface includes power button, mode button, volume control, single speaker, headphone jack and LCD display for heart rate, battery and working mode, probe type. SONOLINE A and SONOLINE B includes four interchangeable probes (2MHz normal probe,2MHz water proof probe,3MHz normal probe,3MHz water proof probe), while Baby Sound A and Baby Sound B are integrated with 2MHz probe.
    Device Description
    Contect Pocket Fetal Doppler includes four models, SONOLINE A. SONOLINE B, Baby Sound A and Baby Sound B. They are handheld, battery powered audio Doppler devices used for detecting fetal heart beats. They are all available for user replaceable batteries. SONOLINE A and SONOLINE B include four interchangeable probes (2MHz normal probe, 2MHz water proof probe, 3MHz normal probe and 3MHz proof resistance probe), while Baby Sound A and Baby Sound B are integrated with 2MHz probe.
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