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510(k) Data Aggregation

    K Number
    K113117
    Device Name
    NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOX
    Manufacturer
    NIHON KOHDEN AMERICA, INC.
    Date Cleared
    2012-03-22

    (153 days)

    Product Code
    GWQ
    Regulation Number
    882.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    NIHON KOHDEN AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EEG-1200A series Nerurofax is intended to record, measure and display cerebral and extracerebral activity for EEG and Sleep Studies. This data may be used by the clinician in sleep disorders, epilepsies and other related disorders as an aid in diagnosis The device is intended for use by medical personnel in any location within a medical facility, laboratory, clinic or nursing home or outside of a medical facility under direct supervision of a medical professional.
    Device Description
    The EEG-1200A with JE-120A is a digital EEG based on a minimum of a 32-bit computer with a filing function. The device uses Windows Graphic User Interface, receives physiological signals (up to 256 channels with JE-120 electrode junction box) from patients and digitizes the signals, the application of the software reproduces the waveforms, The EEG-1200A with JE-120A consists of a main unit, electrode junction box (head box), PC Unit, Isolation Unit and System Programs. The electrode junction box, monitor, keyboard and mouse connect to the computer. The computer and control panel connect to the main unit. Components requiring AC power plug into the main unit's isolated power supply. The main unit plugs into a hospital grade AC power source. All components fit onto a portable cart. A stand is also available for the electrode junction box. Patient data is stored to hard drive or other commercially available digital storage media. Inputs for Sp02 and EtC02 are available.
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    K Number
    K120485
    Device Name
    NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT P
    Manufacturer
    NIHON KOHDEN AMERICA, INC.
    Date Cleared
    2012-03-16

    (28 days)

    Product Code
    OMA, OLT, ORT
    Regulation Number
    882.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    NIHON KOHDEN AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The QP-160AK Trend program is a software-only device intended to be installed on the EEG-1200A series electroencephalograph to record, calculate, and display EEG data obtained from the EEG-1200A system. This device is intended to be used by qualified medical practitioners, trained in Electroencephalography, who will exercise professional judgment when using the information. The intended use for each of the software's outputs is as follows: - The EEG and aEEG waveforms are intended to help the user monitor the state of the brain. - The user-defined Fast Fourier Transform (FFT) parameters of this software (FFT power) are intended to help the user analyze the EEG waveform. - The burst suppression parameters of this software (interval and bursts per minute) are intended to aid in the identification and characterization of areas of burst-suppression pattern in the EEG. This device does not provide any diagnostic conclusion about the patient's condition to the user. The device is intended for use by medical personnel in any location within a medical facility, laboratory, clinic or nursing home or outside of a medical facility under direct supervision of a medical professional.
    Device Description
    The OP-160AK Trend program is a software-only device intended to be installed on the EEG-1200A series electroencephalograph to record, calculate, and display EEG data obtained from the EEG-1200A system. The QP-160AK EEG Trend program is the same as the previous version of QP-160AK cleared under 510k but has two new trends available (DSA Asymmetry trend and FFT Power Asymmetry trend).
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    K Number
    K092573
    Device Name
    NIHON KOHDEN QP-160AK EEG TREND PROGRAM
    Manufacturer
    NIHON KOHDEN AMERICA, INC.
    Date Cleared
    2010-07-09

    (323 days)

    Product Code
    OMA, OLT, ORT
    Regulation Number
    882.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    NIHON KOHDEN AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The QP-160AK Trend program is a software-only device intended to be installed on the EEG-1200A series electroencephalograph to record, calculate, and display EEG data obtained from the EEG-1200A system. This device is intended to be used by qualified medical practitioners, trained in Electroencephalography, who will exercise professional judgment when using the information. The intended use for each of the software's outputs is as follows: - . The EEG and aEEG waveforms are intended to help the user monitor the state of the brain. - . The user-defined Fast Fourier Transform (FFT) parameters of this software (FFT power) are intended to help the user analyze the EEG waveform. - The burst suppression parameters of this software (interval and bursts per . minute) are intended to aid in the identification and characterization of areas of burstsuppression pattern in the EEG. This device does not provide any diagnostic conclusion about the patient's condition to the user.
    Device Description
    The QP-160AK EEG Trend program is a software program stored on electronic media such as CD Rom. The EEG-1200A OP-160AK Trend program is a device which is installed on the electroencephalograph EEG-1200A Series and records the EEG waveforms and identifies trends in the EEG data over extended periods of time in order for trained health care professionals to observe changes over time. The QP-160AK design features are as follows: - Trend display of aEEG and Burst suppression ratio . - Display of EEG waveform maximum of 64 channels - DC Trend display including analog inputs . - Operations of functions by control buttons adapted to touch panels . - Data management by NeuroWorkbench .
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    K Number
    K083456
    Device Name
    NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970P
    Manufacturer
    NIHON KOHDEN AMERICA, INC.
    Date Cleared
    2009-03-02

    (101 days)

    Product Code
    CCK
    Regulation Number
    868.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    NIHON KOHDEN AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nihon Kohden TG-970P Series CO2 Sensor Kit is intended for medical purposes to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory status. Along with other methods indicated by the physician for medical diagnosis, this device is intended as an indicator of patient carbon dioxide concentration during expiration.
    Device Description
    The Nihon Kohden CO2 Sensor Kit, model number TG-970P Series, is intended for medical purposes to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory (end tidal CO2) status. The device measuring technique is through absorption of infrared radiation. The airway adapter is a Single -Patient Use disposable product. The device is intended as an indicator of patient carbon dioxide concentration during expiration for intubated patients. The device is intended for use with patients weighing 7kg or more. The device is not recommended for patients with low tidal volume such as patients weighing less than 7kg or patients with a respiration rate greater than 150 breaths per minute.
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    K Number
    K083271
    Device Name
    BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001 SERIES OPTIONAL ACCESSORY
    Manufacturer
    NIHON KOHDEN AMERICA, INC.
    Date Cleared
    2008-12-24

    (48 days)

    Product Code
    MHX
    Regulation Number
    870.1025
    Why did this record match?
    Applicant Name (Manufacturer) :

    NIHON KOHDEN AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to monitor the electrocardiogram to generate audible and/or visible alarms when an arrhythmia exists. The device is also intended to monitor heart rate, pulse rate, blood oxygen saturation (SpO2), noninvasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, carbon dioxide concentration (CO2 and EtCO2), and respiratory rate. The device may generate an audible and/or visible alarm when a measured rate falls outside preset limits. The device may also condition and transmit physiological signals via radio frequency. This will be available for use by medical personnel on all patient populations.
    Device Description
    The CGS-9001A Series Communication Gateway Server is an Optional Accessory to the BSM-2300A and BSM-6000 Bedside Monitors, it is a software product that allows the Nihon Kohden Patient Monitoring System to transfer alarm event information from the monitoring device to a third party system. The Communication Gateway Server collects alarm information from all networked patient monitors in a Nihon Kohden Patient Monitoring System and forwards it to a commercially available third party Secondary Alarm Notification System. The alarm notification generated by the third party alarm (not marketed by Nihon Kohden America, Inc.) is for Secondary Alarm Notification Only.
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    K Number
    K082785
    Device Name
    NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIES
    Manufacturer
    NIHON KOHDEN AMERICA, INC.
    Date Cleared
    2008-11-26

    (64 days)

    Product Code
    MHX
    Regulation Number
    870.1025
    Why did this record match?
    Applicant Name (Manufacturer) :

    NIHON KOHDEN AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signals produced by the heart and monitor the electrocardiogram to generate visible and/or audible alarms when an arrhythmia exists. The device is also intended to monitor heart rate, pulse rate, blood oxygen santuation (SpO2), noninvasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, Cardiac Output (CO), oxygen concentration (FiO2), Carbon dioxide Concentration (C02) and EtCO2 respiratory rate, BIS and inspired and expired anesthetic agents and gases including CO2, O2, N2O, Halothane, Isoflurane, Enflurane, Sevoofburane and Desflurane. Anesthetic agents and gases are detected using the cleared AG-920RA Anesthetic Agent Detection System K020046 cleared for distribution on July 23, 2002. The device also monitors Ventilators, CO2 Monitors, TOF Monitors, BIS Monitors and CCO/SvO2 Monitors .The device may generate an audible and/or visual alsommore a measured rate falls outside preset limits.
    Device Description
    Bedside Monitor, Patient Monitor, Cardiac Monitor, Vital Signs Monitor and Anesthesia Monitor.
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    K Number
    K071969
    Device Name
    SEN-4100 ELECTRIC STIMULATOR
    Manufacturer
    NIHON KOHDEN AMERICA, INC.
    Date Cleared
    2008-10-06

    (447 days)

    Product Code
    GWF
    Regulation Number
    882.1870
    Why did this record match?
    Applicant Name (Manufacturer) :

    NIHON KOHDEN AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Nihon Kohden Sen-4100 Electric Stimulator is used for the intraoperative diagnosis of acute dysfunction in corticospinal tract axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.
    Device Description
    The SEN-4100A is the stimulator to output electrostimulation pulses. It conducts the constant voltage stimulation that is necessary for MEP (Motor Evoked Potential) measurement, from an electrophysiological viewpoint, diagnosing and analyzing the neuromuscular action potential for a patient provided with anesthesia care in an operating room.
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    K Number
    K080546
    Device Name
    NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A
    Manufacturer
    NIHON KOHDEN AMERICA, INC.
    Date Cleared
    2008-08-29

    (183 days)

    Product Code
    OLT, GWQ, OLV
    Regulation Number
    882.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    NIHON KOHDEN AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EEG-1200A Series Neurofax is intended to record, measure and display cerebral and extracerebral activity for EEG and Sleep Studies. These data may be used by the clinician in Sleep Disorder, Epilepsies and other related disorders as an aid in diagnosis. The device is intended for use by medical personnel in any location within a medical facility, laboratory, clinic or nursing home or outside of a medical facility under direct supervision of a medical professional.
    Device Description
    The EEG-1200A Electroencephalograph is the instrument to provide the information for intervention to utilize derivation, recording, analysis, or each combination of the brain's action potential. The instrument can measure the vital signal (including ECG waveform, EMG waveform, respiration waveform, ocular motility, SpO2 and CO2) in relation to EEG examination and display the waveform on the screen changing the montage and amplifier conditions. In addition, measurement data is available to file into the electric media. Changing the montage and amplifier conditions, then record to the printer, previews the measured data filed into the electric media. EEG data analysis is also executed to use the analysis software.
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    K Number
    K073550
    Device Name
    PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATION
    Manufacturer
    NIHON KOHDEN AMERICA, INC.
    Date Cleared
    2008-03-28

    (101 days)

    Product Code
    MHX
    Regulation Number
    870.1025
    Why did this record match?
    Applicant Name (Manufacturer) :

    NIHON KOHDEN AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Prefense EDNS-9000 Series Central Nurse Station is intended for use by medical professionals to provide cardiac and vital signs monitoring for multiple patients within a medical facility. The Prefense EDNS-9000 Series Central Nurse Station will display and record physiological data from up to forty telemetry receivers/transmitters and generates an alarm when a measured parameter falls outside a preset limit or when an arrhythmia is detected. Arrhythmia detection and alarm determination are functions of the telemetry receivers/transmitters or individual beside monitor. The Prefense EDNS-9000 Series Central Nurse Station is intended for cardiac and vital signs monitoring for multiple patients. The device will display and record physiological data from telemetry receivers/transmitters and alarms when a measured parameter falls outside a preset limit or when an arrhythmia is detected by the telemetry unit. This product will be available for use by medical personnel on all patient populations with a medical facility.
    Device Description
    The Prefense EDNS-9000 Series Central Nurse Station is intended for use by medial professionals to provide cardiac and vital signs monitoring for multiple patients within a medical facility. The Prefense EDNS-9000 Series Central Nurse Station will display and record physiological data from up to forty telemetry receiver/transmitters and generates an alarm when a measured parameter falls outside a pre-set limit or when life threatening arrhythmia is detected. Arrhythmia detection and alarm determination are functions of the telemetry receivers (Model ORG-9700 Multiple Patient Receiver, per 510K K071058 Commercial distribution certification dated June 29, 2007) transmitter (Model ZS-940PA, per 510(k) K043517 Commercial Distribution certification dated February 3, 2005). The new device receives a small subset (non-invasive telemetry parameters) all of the same information as the predicate device, i.e., receives physiological signal from telemetry transmitters/receivers from ORG 9700 Multiple Patient Receiver signal simultaneously, receives and displays physiological information. generates audible and/or visual alarm indictors when an alarm violation is detected by the telemetry units, stores waveforms for review and printing as full disclosure, stores tabular and graphical trending data for review and printing, provides network communications using commercially available LAN/WAN products, provides remote data access through NetProse access software and records and prints physiological patient data.
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    K Number
    K080342
    Device Name
    NIHON KOHDEN BEDSIDE MONITOR, MODEL BSM-6000S SERIES
    Manufacturer
    NIHON KOHDEN AMERICA, INC.
    Date Cleared
    2008-02-26

    (18 days)

    Product Code
    MHX
    Regulation Number
    870.1025
    Why did this record match?
    Applicant Name (Manufacturer) :

    NIHON KOHDEN AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signals produced by the heart and monitor the electrocardiogram to generate audible and/or visible alarms when an arrhythmia exists. The device is also intended to monitor heart rate, blood oxygen saturation (SpO2), non-invasive blood pressure (NIBP), continuous non-invasive blood pressure (CNIBP), invasive blood pressure (IBP), body temperature, BIS, Cardiac Output (CO), oxygen concentration (FiO2), carbon dioxide concentration (CO2) and EtCO2, respiratory rate and inspired and expired anesthetic agents and anesthetic gases including N20, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane. The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits. This device may also be used to condition and transmit physiological signals via radio frequency.
    Device Description
    The device is intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signals produced by the heart and monitor the electrocardiogram to generate visible and/or audible alarms when an arrhythmia exists. The device is also intended to monitor heart rate, pulse rate, blood oxygen saturation (SpO2), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, Cardiac Output (CO), oxygen concentration (FiO2), CO2 and EtCO2, respiratory rate, BIS and inspired and expired anesthetic agents and gases including CO2, O2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane. Anesthetic agents and gases are detected using the cleared AG-920RA Anesthetic Agent Detection System. The device can interface to external equipment to display numerical and waveform data and alarms from the external devices. Supported external devices include AG-920RA Anesthetic Agent Detection System, Ventilators, CO2 Monitors, TOF Monitors, BIS Monitors, CCO/SvO2 Monitors and continuous NIBP Monitors. The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits. This device may also be used to condition and transmit physiological signals via radio frequency.
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