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510(k) Data Aggregation
K Number
K231778Device Name
Nihon Kohden NKV-550 Series Ventilator System
Manufacturer
Nihon Kohden OrangeMed, LLC
Date Cleared
2024-03-01
(259 days)
Product Code
CBK
Regulation Number
868.5895Why did this record match?
Applicant Name (Manufacturer) :
Nihon Kohden OrangeMed, LLC
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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