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Bionet Co., Ltd.

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Contact: Dong-Joo Kang
Web: http://www.bionetkorea.com
E-Mail:
Address: No. 1101 E&c Venture Dream Tower, 3rd 197-33, Guro-Dong, Guro-Gu, Seoul 152-050, Korea, Republic Of
Phone: +82-(2)-63006410 | Fax: +82-(2)-63006425 | Map/Directions >>
 
 

Profile: Bionet Co., Ltd. is a medical device manufacturing and sales company. We specialize in bio-signal products. Electrocardiography, patient monitor & fetal monitor are our main products, but we also offer anesthesia device target controlled infusion pump. Our products are ECG, fetal care, patient monitor, and syringe pump. BM3 & BM5 patient monitors provides ECG, SpO2, NIBP, respiration, 2 IBPs, 2 temps and EtCO2. HealthKeeper X provides abdominal obesity measurement.

The company is ISO 9002, CE certified.

FDA Registration Number: 3003681187
US Agent: Hyun Y.seo / Bionet America, Inc.
Phone: +1-(714)-734-1760  Fax: +1-(714)-734-1761  E-Mail:

4 Products/Services (Click for related suppliers)  
• Ecg Analysis System (FDA Code: LOS)
• Patient Physiological Monitor without Arrhythmia Detection (FDA Code: MWI / 870.2300)
A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.
• Perinatal Monitoring System (FDA Code: HGM / 884.2740)
A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of device may include any of the devices subject to 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. This generic type of device may include the following accessories: Central monitoring system and remote repeaters, signal analysis and display equipment, patient and equipment supports, and component parts.
• Ultrasonic Blood Flow Monitor (FDA Code: HEP / 884.2660)
A fetal ultrasonic monitor is a device designed to transmit and receive ultrasonic energy into and from the pregnant woman, usually by means of continuous wave (doppler) echoscopy. The device is used to represent some physiological condition or characteristic in a measured value over a period of time (e.g., perinatal monitoring during labor) or in an immediately perceptible form (e.g., use of the ultrasonic stethoscope). This generic type of device may include the following accessories: signal analysis and display equipment, electronic interfaces for other equipment, patient and equipment supports, and component parts. This generic type of device does not include devices used to image some relatively unchanging physiological structure or interpret a physiological condition, but does include devices which may be set to alarm automatically at a predetermined threshold value.

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