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510(k) Data Aggregation
K Number
K222644Device Name
Nihon Kohden NKV-440 Ventilator System
Manufacturer
Nihon Kohden OrangeMed, Inc.
Date Cleared
2023-05-31
(272 days)
Product Code
CBK
Regulation Number
868.5895Why did this record match?
Applicant Name (Manufacturer) :
Nihon Kohden OrangeMed, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nihon Kohden NKV-440 Ventilator System is intended to provide continuous ventilation for adult, pediatric and neonatal patients who require invasive or noninvasive respiratory support. The NKV-440 offers mandatory and spontaneous ventilation modes as well as respiratory monitoring. The NKV-440 is intended for use in hospitals and hospital-type facilities, as well as, for in-hospital transportation.
Device Description
The NKV-440 is a servo-controlled ventilator that is designed to meet the gas delivery and performance requirements for neonate through adult patients. The NKV-440 design is comprised of two major components, a Breath Delivery Unit (BDU) and a Graphic User Interface (GUI). The GUI allows clinicians to set ventilator control parameters such as PEEP and inspiratory pressure, to set alarm limits such as high inspiratory pressure alarm, to view monitored numeric values, and to view waveforms. The BDU assembly contains a blower and the electronics required to perform breath delivery. Ambient air is taken into the blower and mixed with oxygen which is flow rate controlled by a proportional valve. The mixed gas is provided to the patient. The microprocessor controls the blower and the proportional valve to deliver the pressure and oxygen concentration which are set by the user. It also provides various alarms and other design features to maximize patient safety.
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K Number
K213521Device Name
Nihon Kohden NKV-330 Ventilator System
Manufacturer
Nihon Kohden OrangeMed, Inc.
Date Cleared
2022-07-01
(240 days)
Product Code
MNT
Regulation Number
868.5895Why did this record match?
Applicant Name (Manufacturer) :
Nihon Kohden OrangeMed, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nihon Kohden NKV-330 Ventilator is intended to provide ventilation and oxygen concentration for patients who are breathing spontaneously but need partial ventilation support due to respiratory failure or chronic respiratory insufficiency. It is intended for children weighing 12.5 kg or greater to adult patients. It offers noninvasive ventilation, invasive ventilation, and respiratory monitoring. The NKV-330 is intended for use in hospital-type facilities, and in-hospital transportation by qualified and trained users under the directions of a physician.
Device Description
The NKV-330 is a servo-controlled ventilator that is designed to meet the gas delivery and performance requirements for pediatric through adult patients. The NKV-330 design is comprised of two major components, a Breath Delivery Unit (BDU) and a Graphic User Interface (GUI). The GUI allows clinicians to set ventilator control parameters such as PEEP and inspiratory pressure, to set alarm limits such as high inspiratory pressure alarm, to view monitored numeric values, and to view waveforms. The BDU assembly contains a blower and the electronics required to perform breath delivery. Ambient air is taken into the blower and mixed with oxygen which is flow rate controlled by a proportional valve. The mixed gas is provided to the patient. The microprocessor controls the blower and the proportional valve to deliver the pressure and oxygen concentration which are set by the user. It also provides various alarms and other design features to maximize patient safety.
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K Number
K192307Device Name
Nihon Kohden NKV-550 Series Ventilator System
Manufacturer
Nihon Kohden OrangeMed, Inc.
Date Cleared
2020-01-10
(137 days)
Product Code
CBK
Regulation Number
868.5895Why did this record match?
Applicant Name (Manufacturer) :
Nihon Kohden OrangeMed, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nihon Kohden NKV-550 Series Ventilator System is intended to provide continuous ventilation for adult, pediatric and neonatal patients who require invasive or noninvasive respiratory support. The NKV-550 offers mandatory and spontaneous ventilation modes as well as respiratory monitoring. The NKV-550 is intended for use in hospitals and hospital-type facilities, as well as, for in-hospital transportation.
Device Description
The Nihon Kohden NKV-550 Series Ventilator System consists of a graphic user interface (GUI) and a breath delivery unit (BDU). The GUI allows clinicians to set ventilator control parameters such as tidal volume and inspiratory pressure, to set alarm limits such as high inspiratory pressure alarm, to view monitored numeric values, to view waveform and loops, and to operate various features through the apps. The BDU contains a microprocessor that receives inputs from the electronic system and controls the pneumatic system for breath delivery to the patient. It also provides various alarms, a safety valve, and other design features to maximize patient safety.
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K Number
K181695Device Name
Nihon Kohden NKV-550 Series Ventilator System
Manufacturer
Nihon Kohden OrangeMed, Inc.
Date Cleared
2018-12-07
(163 days)
Product Code
CBK
Regulation Number
868.5895Why did this record match?
Applicant Name (Manufacturer) :
Nihon Kohden OrangeMed, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nihon Kohden NKV-550 Series Ventilator System is intended to provide continuous ventilation for adult, pediatric and neonatal patients who require invasive or noninvasive respiratory support. The NKV-550 offers mandatory and spontaneous ventilation modes as well as respiratory monitoring. The NKV-550 is intended for use in hospitals and hospital-type facilities, as well as, for in-hospital transportation.
Device Description
The Nihon Kohden NKV-550 Series Ventilator System consists of a graphic user interface (GUI) and a breath delivery unit (BDU). The GUI allows clinicians to set ventilator control parameters such as tidal volume and inspiratory pressure, to set alarm limits such as high inspiratory pressure alarm, to view monitored numeric values, to view waveform and loops, and to operate various features through the apps.
The BDU contains a microprocessor that receives inputs from the electronic system and controls the pneumatic system for breath delivery to the patient. It also provides various alarms, a safety valve, and other design features.
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