Search Filters

Search Results

Found 10 results

510(k) Data Aggregation

    K Number
    K232893
    Device Name
    Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)
    Manufacturer
    Contec Medical Systems Co., Ltd.
    Date Cleared
    2024-06-14

    (270 days)

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

    Contec Medical Systems Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pocket Fetal Doppler (Models CONTEC 10D, CONTEC 10E and CONTEC10F) is used to detect the fetal heart rate. The device should be used by health care professionals including nurses, midwives, and specialized technicians in the hospital, clinic, community and home. The device is intended for use at or after 12 weeks gestation.
    Device Description
    The Pocket Fetal Doppler is a hand-held fetal Doppler used for non-invasive measurement and numerical display of the fetal heart rate (FHR) utilizing pulsed-wave Doppler ultrasound. The Pocket Fetal Doppler includes three models: CONTEC10E and CONTEC10E and CONTEC10F. All models have four components: upper shell, display and probe. The material for probe cap and shell is ABS. The device contains an ultrasonic signal transmitter and receiver, analog signals processing unit, FHR calculating unit, and LCD display control unit. The device is used to detect the fetal heart rate. The device should be used by health care professionals including nurses, midwives, and specialized technicians in hospital, clinic, community and home. This device can detect a fetal heart rate value at or after twelve weeks gestation. The CONTEC10D is powered by a 3.7V lithium battery, the ultrasonic signal is continuously transmitted at a frequency of 2.5MHz. The CONTEC10E and CONTEC10F is powered by two 1.5V batteries (AA LR6), the ultrasonic signal is continuously transmitted at a frequency of 2.5MHz.
    Ask a Question
    K Number
    K232895
    Device Name
    B-Ultrasound Diagnostic System
    Manufacturer
    Contec Medical Systems Co., Ltd.
    Date Cleared
    2024-05-03

    (228 days)

    Product Code
    IYO, ITX
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    Contec Medical Systems Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    B-Ultrasound Diagnostic System in a general-purpose, digital ultrasound diagnostic system for abdomen, gynecology, obstetric, urology, and small-parts application. The system is intended to use for the following type of studies: fetal organ, abdominal, pediatric, small organs (Thyroid, Galactophore, Testis), neonatal cephalic, peripheral vasculo-skeletal (both conventional and superficial), The device is intended to adult, pregnant woman, pediatric and neonate. The system is a prescription device intended to be used by or on the order of a physician or similar qualified health care professional. This device is not intended for home use. Modes of operation include B, M, PWD(PW), B+M, 2B, 4B.
    Device Description
    B-Ultrasound Diagnostic System in a general-purpose, digital ultrasound diagnostic system for abdomen, gynecology, obstetric, urology, and small-parts application. The system is intended to use for the following type of studies: fetal organ, abdominal, pediatric, small organs, neonatal cephalic, peripheral vascular, and musculo-skeletal (both conventional and superficial). The device is intended to adult, pregnant woman, pediatric and neonate. The system is a prescription device intended to be used by or on the order of a physician or similar qualified health care professional. This device is not intended for home use. Modes of operation include B, M, PWD(PW), B+M, 2B, 4B. Please refer to the acoustic output declaration for each transducer as following pages. B-Ultrasound Diagnostic System is a Track 3, diagnostic ultrasound system, which has a main unit and two probes (Broadband convex array probe and Broadband convex array probe), powered by a 14.4V lithium battery, the ultrasonic signal is continuously transmitted at a frequency of 2-12MHz. The B-Ultrasound Diagnostic System of six functional modules: Power module, Ultrasound front-end module, Keyboard module, Industrial control board, LCD screen, and Interface board. When electrical pulses are applied to the piezoelectric wafer (transducer), it will produce ultrasound waves of a certain frequency, which will enter the human body. Due to the ultrasound waves traveling through different tissues in the human body with different acoustic impedances (caused by differences in density and ultrasound transmission speed), the reflected echoes generated by the surfaces of different organs in the human body will be different. The reflected echoes of different sizes will be received by the piezoelectric wafer, and then converted into electrical pulse signals. After digital beamforming and other processing, those signals are formed into standard video signals that can be displayed on the monitor screen as cross-sectional images of the organ.
    Ask a Question
    K Number
    K232908
    Device Name
    Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound Diagnostic System (CMS1700C)
    Manufacturer
    Contec Medical Systems Co., Ltd.
    Date Cleared
    2024-05-02

    (226 days)

    Product Code
    IYN, ITX, IYO
    Regulation Number
    892.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    Contec Medical Systems Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Color Doppler Ultrasound Diagnostic System is a general-purpose ultrasound system. It is intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment. The systems support the following clinical applications: Ultrasound examination and diagnosis of abdomen, obstetrics, gynecology, small organ (Thyroid, Galactophore, Testis) and cardiac. Modes of operation include: 3D Imaging mode, B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Combined modes: B/M, B/Color M, B/PWD , B/Color/PWD ,B/Power/PWD.
    Device Description
    The apparatus is high resolution ultrasound diagnostic system, which adopts digital beam forming(DBF), real-time dynamic aperture(RDA), real-time dynamic beam apodization (DRA), real-time dynamic receive focusing (DRF), digital-control dynamic frequency scanning (DFS), frame correlation etc. technologies. The image is clear, stable, and high resolution. It adopts embedded operating system, which greatly improve the product security and compatibility, and enhance the data processing ability. The apparatus is taken more conveniently for its humane operation interface and management system, flexible expansibility and compatibility, pop-up menu and keyboard design. Users can chose different kinds of display modes,such as:B, 2B, 4B, BM, M. Image real-time, freeze, memory, calling up and large capability cine loop can be realized; the device possesses multilevel scanning depth, dynamic range, sound output power and focus number, focus space, focus position adjusting etc. functions. With controllable frame correlation, gamma correction, image reversing, histogram, depth advance, zoom magnification, no distortion real-time part magnification etc. abundant image processing functions. It is convenient for choice of optimal diagnostic image with perfect image pigeonhole, browse, management functions. Measure, calculation, and report are even complete and convenient with powerful measure software package and perfect measurement. The device supports linear probe and convex probe. It has extensive application that is suitable for clinic diagnosis, such as abdomen, obstetrics, gynecology, small organs, cardiology etc. .
    Ask a Question
    K Number
    K220245
    Device Name
    Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)
    Manufacturer
    Contec Medical Systems Co., Ltd.
    Date Cleared
    2022-09-28

    (243 days)

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

    Contec Medical Systems Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) is used to detect the fetal heart rate. The device should be used by health care professionals including nurses, midwives, and specialized technicians in the hospital, clinic, community and home. The device is intended for use at or after 12 weeks gestation.
    Device Description
    The Pocket Fetal Doppler is a hand-held FHR detection device, it is used for non-invasive measurement and display of the fetal heart rate (FHR) utilizing Doppler ultrasound. The Pocket Fetal Doppler consists of two models (CONTEC10C, CONTEC10CL). Both models have two hand-held components, a main unit and a probe. The device contains components of ultrasonic signal transmitter and receiver, analog signals processing unit, FHR calculating unit, and LCD display control unit.
    Ask a Question
    K Number
    K202757
    Device Name
    CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure Monitor
    Manufacturer
    Contec Medical Systems Co., Ltd.
    Date Cleared
    2021-04-28

    (219 days)

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

    Contec Medical Systems Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Electronic Sphygmomanometer and Automatic Blood Pressure Monitor are intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique at medical facilities or at home.
    Device Description
    The proposed devices, ABPM50 Automaitc Blood Pressure Monitor, CONTEC08A and CONTEC08C Electronic Sphygmomanometers are battery driven automatic non-invasive Blood Pressure Monitor. They can automatically complete the inflation and BP measurement, which can measure systolic, and diastolic 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 and CONTEC08A and CONTEC08C can be only used on adult individuals. The devices have the data storage function for data review including measurement time, systolic blood pressure, diastolic blood pressure and pulse rate. ABPM50 and CONTEC08A have physiological over-limit prompt function which can be turned on or off by users. When the measurement results exceed the over-limit prompt limit, the physiological over-limit prompt function will be triggered. The over-limit can be set by users, and the low limit must be lower than the corresponding high limit. In addition, all of the three proposed devices have technical over-limit prompt function, which will be triggered when the battery voltage is low, and this technical over-limit prompt function can not be cancelled unless being closed or the power replaced.
    Ask a Question
    K Number
    K201980
    Device Name
    Infrared Thermometer
    Manufacturer
    Contec Medical Systems Co., Ltd.
    Date Cleared
    2020-12-18

    (155 days)

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

    Contec Medical Systems Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TP500 Infrared Thermometer is intended to measure human body temperature by measuring from 1-3cm distance to the forehead. The device can be used on people of all ages. It is recommended that the device be operated by an adult. The device is intended to be used in the hospital and other clinical environments.
    Device Description
    The Infrared thermometer (model TP500) is a hand-held, battery powered, electronic thermometer that converts a subject's forehead temperature, using the infrared energy emitted in the area around the subject's forehead to an oral equivalent temperature when measured from 1-3cm to the center of the subject's forehead with no contact. The device can be used on people of all ages and is intended to be used in the hospital and other clinical environments.
    Ask a Question
    K Number
    K171360
    Device Name
    CONTEC™ Electrocardiograph
    Manufacturer
    Contec Medical Systems Co., LTD.
    Date Cleared
    2018-01-22

    (258 days)

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

    Contec Medical Systems Co., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CONTEC™ Electrocardiograph, ECG90A, is intended to acquire ECG signals from adult or children patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. The proposed devices also have measurements and diagnostic interpretation functions, which are offered to clinician on an advisory basis. Digital Electrocardiographs shall be used in healthcare facilities by doctors and or trained healtheare professionals.
    Device Description
    This product is an electrocardiograph collecting 12-lead ECG signal simultaneously and printing ECG waveform with thermal printing system, which features in, recording and displaying ECG waveform with manual or auto mode, measuring and diagnosing ECG waveform parameters automatically, prompting for "Lead off" and "Lack of paper", optional interface languages(Chinese/ English), case database management. This product is used to assist doctors to analyze and print the ECG waveform of children and adults, which can be applied to ECG room, ward, hospital, etc. The ECG machine provides medical department human ECG wave group for pattern and rhythm analysis that applied in clinical diagnosis and research. Essential Performance:Sync collection and display of 12-lead ECG.Display of HR.Print ECG wave with different format,Filter settings,and Auto-measurement of ECG data. ECG90A is divided into button system, printing system, power supply system, LCD display system, signal collection system, control system Button system: to collect the user's key operation input, send the control system to process, Printing system: print the print data sent by the control system, heat the printer head to record the waveform on the thermal printing paper, and feedback whether the lack of paper; Power system: provide power supply for each system module; The proposed device adopts two kinds of power supply modes: build-in lithium battery DC power supply and AC-DC adapter power supply. AC-DC adapter power supply: after the external power adapter connecting with the proposed device, the AC voltage is reduced to 12V via the AC-DC power adapter. The 12V voltage is used to charge the lithium battery via the charging management chip;meanwhile the 12V voltage is reduced to 8.6V via a voltage converter, which is used to power the following circuit and printer. Then the 8.6V voltage is reduced again to 5.0V voltage via the voltage converter, and the 5.0V voltage pass through power isolation and is used to power the signal collection and processing module; meanwhile the 5V voltage will be reduces to 3.3 Vvoltage, which is used to power the control module. Build-in lithium battery DC power supply: when the proposed device is connected with AC-DC adapter power supply, the build-in lithium battery will be charged automatically. The charged battery will power the whole system as DC power supply when the proposed device is not connected with the external AC-DC adapter power supply LCD display system: display various of settings of waveform information to the user for viewing : Signal collection system: collect the waveform data,submit the final data to the control system to process; the signal acquisition and process module adopts floating and optical isolation to reduce the external disturbance to signal. After filtering and amplification, the A/C conversion of acquired ECG signal is completed on MCU (Micro Controller Unit); and then the data is transmitted to control system. after processing the data will be displayed on the LCD screen and the waveform will be printed on the thermal paper. MCU can identify and response the key operation through connecting line, and MCU can connect and communicate with the SD card and USB through the signal line. Control system: the MCU is used to control the whole system operation. The device parameters setting, the processing of acquired signal, the printing, screen display and charging are all controlled by this module.
    Ask a Question
    K Number
    K170856
    Device Name
    CMS600P2 B-Ultrasound Diagnostic System
    Manufacturer
    Contec Medical Systems Co., LTD.
    Date Cleared
    2017-11-17

    (240 days)

    Product Code
    IYO, ITX
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    Contec Medical Systems Co., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CMS600P2 B-Ultrasound Diagnostic System in a general-purpose, digital ultrasound diagnostic system for abdomen,gynecology, obstetric, urology,and small-parts application. The system is intended to use for the following type of studies: fetal organ, abdominal, pediatric, small organs, neonatal cephalic, transvaginal, peripheral vascular,and musculo-skeletal (both conventional and superficial). The device is intended to adult, pregnant woman, pediatric and neonate. The system is a prescription device intended to be used by or on the order of a physician or similar qualified health care professional. This device is not intended for home use.
    Device Description
    The apparatus is high resolution ultrasound diagnostic system, which adopts digital beam forming(DBF), real-time dynamic aperture(RDA), real-time dynamic beam apodization (DRA), real-time dynamic receive focusing (DRF), digital-control dynamic frequency scanning (DFS), frame correlation etc. technologies. The image is clear, stable, and high resolution. It adopts embedded operating system, which greatly improve the product security and compatibility, and enhance the data processing ability. The apparatus is taken more conveniently for its humane operation interface and management system, flexible expansibility and compatibility, pop-up menu and keyboard design. Users can chose different kinds of display modes,such as:B, 2B, 4B, BM, M. Image real-time, freeze, memory, calling up and large capability cine loop can be realized; the device possesses multilevel scanning depth, dynamic range, sound output power and focus number, focus space, focus position adjusting etc. functions. With controllable frame correlation, gamma correction, image reversing, histogram, depth advance, zoom magnification, no distortion real-time part magnification etc. image processing functions. It is convenient for choice of optimal diagnostic image with image pigeonhole, browse, management functions. Measure, calculation, and report features are provided to facilitate image measurement. The device supports linear probe and convex probe. The frequency of the device is 2.0 MHz-10.0 MHz. It has extensive application that is suitable for clinic diagnosis, such as abdomen, obstetrics, gynecology, small organs, cardiology and urology etc. . The device is consist of three parts: mainframe, transducer(probe), adapter.
    Ask a Question
    K Number
    K141362
    Device Name
    PULSE OXIMETER CMS50EW
    Manufacturer
    CONTEC MEDICAL SYSTEMS CO., LTD.
    Date Cleared
    2015-04-23

    (335 days)

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

    CONTEC MEDICAL SYSTEMS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pulse Oximeter CMS50EW is a non-invasive device intended for spot-check or continuous monitoring of non-invasive oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate through the finger of adult patients in home and hospital environments (including clinical use internist/surgery, anesthesia, and intensive care settings). The device is reusable and not intended for out-of-hospital transport use.
    Device Description
    The proposed device, Pulse Oximeter CMS50EW is a battery powered fingertip device, which can display % SpO2, pulse rate value and pulse strength. It is based on digital blood oxygen technology. The proposed device is composed of power module, signal acquisition module, control and signal processing module. The power source of it is a built-in rechargeable lithium battery. And it has alarm function, to raise the user's attention for exceeding of physiological limit and device error via visual and audio alarming indicator. And the pulse oximeter can communicate with computer by USB data wire and Bluetooth. The proposed device, Pulse Oximeter CMS50EW, is a modification to the predicate device, CMS50E, cleared under K090671; the modification is to add the blue tooth functionality, however, the oximetry technology including the sensor was unchanged.
    Ask a Question
    K Number
    K110775
    Device Name
    ELECTRONIC SPHYGMOMANOMETER
    Manufacturer
    CONTEC MEDICAL SYSTEMS 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 SYSTEMS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CONTEC08C 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 individuals.
    Device Description
    The proposed device, CONTEC08C Electronic Sphygmomanometer is battery driven automatic non-invasive Blood Pressure Monitor. The device 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. It can be only used on adult 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. The device has technical alarm function which will be triggered when the battery voltage is lower than 3.7V, and this alarm can not be cancelled unless being closed or the power replaced.
    Ask a Question

    Page 1 of 1