Profile: Nihon Kohden America, Inc. manufactures, develops and distributes medical electronic equipment. We are an ISO-9001, EN 46001, ISO 13485, ISO 17025 & EC certified company. Our product line includes patient monitors, electroencephalographs, evoked potential & electromyography systems, electrocardiographs, defibrillators, cardiac catheterization equipment and veterinary hematology analyzers. We supply compact, lightweight patient transmitters for wireless bedside monitors & wireless networks. We significantly contribute to the advancement of modern medical treatment with many innovative products and technologies. We design and manufacture medical equipment in conformity with the standards of IEC601-1. Our wide range of imported equipment includes cardiology, urology, respiratory care, anesthesiology, emergency care, sports medicine and rehabilitation. We supply high quality medical equipment all over the world.

The company was founded in 1951, has revenues of USD 500 Million to 1 Billion, has ~3370 employees and is ISO 9001, CE certified. TYO:6849 (SEC Filings)

FDA Registration Number: 9611252
US Agent: Thomas Bento / Nihon Kohden America, Inc.
Phone: +1-(949)-680-9048  Fax: +1-(913)-273-0732  E-Mail:

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• Non-Normalizing Quantitative Electroencephalograph Software (FDA Code: OLT / 882.1400) An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.

• Nuclear Uptake Probe (FDA Code: IZD / 892.1320) A nuclear uptake probe is a device intended to measure the amount of radionuclide taken up by a particular organ or body region. This generic type of device may include a single or multiple detector probe, signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

• Orthostatic Vital Signs Monitors

• Oximeters (FDA Code: DQA / 870.2700) An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.

• Oximetry

• Paper Chart Recorder (FDA Code: DSF / 870.2810) A paper chart recorder is a device used to print on paper, and create a permanent record of the signal from, for example, a physiological amplifier, signal conditioner, or computer.

• Patient Monitor Computer

• Patient Physiological Monitor (FDA Code: MHX / 870.1025) The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.

• 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.

• Pediatric Polysomnography Kits

• Pediatric Pulse Oximeter

• Pediatric Vital Signs Monitors

• 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.

• Periodontal Probes

• Peristaltic Infusion Pump (FDA Code: FRN / 880.5725) An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

• Physiological Neonatal Monitor

• Physiological Signal Amplifier (FDA Code: GWL / 882.1835) A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram).

• Physiological Signal Conditioner (FDA Code: GWK / 882.1845) A physiological signal conditioner is a device such as an integrator or differentiator used to modify physiological signals for recording and processing.

• Polygraph

• Polysomnography Ambulatory Data Collection Kits

• Polysomnography Amplifiers

• Polysomnography Analog Devices

• Polysomnography LCD Screen Data

• Polysomnography Neurodiagnostic Systems

• Polysomnography Real-time Monitoring Device

• Polysomnography Sleep Study Systems

• Polysomnography Video Recording Device

• Portable Polysomnography Kits

• Portable Pulse Oximeter

• Pressure Airflow Sensors

• Probes (FDA Code: HXB / 888.4540) An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.

• Probes (FDA Code: HXB / 888.4540)

• Product Development, Pulse Oximeter

• Pulmonary Function Predicted Values Calculator (FDA Code: BTY / 868.1890) A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.

• Pulse Oximeter Accessories

• Pulse Oximeter Adapter Cables

• Pulse Oximeter Connector Cables

• Pulse Oximeter Finger Clip

• Pulse Oximeter Machines

• Pulse Oximeter Patient Cable

• Pulse Oximeter Probe Wrap

• Pulse Oximeter Sensor Repair Kits

• Pulse Oximeter Sensors Service and Repair

• Pulse Oximeter Simulator

• Pulse Oximeter with Artefact Suppression and one channel ECG

• Pulse Oximeter with Charger

• Pulse Oximeter with One Channel ECG

• Pulse Oximeters

• Pulse Oximetry

• Pulse Oximetry Belts