Nihon Kohden NKV-440 Ventilator System - HSA Registration DE0509453
Access comprehensive regulatory information for Nihon Kohden NKV-440 Ventilator System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0509453 and owned by Nihon Kohden OrangeMed, LLC. The device was registered on June 25, 2024.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
The Nihon Kohden NKV-440 Ventilator System is intended to provide continuous ventilation using medical oxygen and an internal source of air to deliver oxygen concentrations of 21 to 100%. Ventilatory support is intended to be delivered invasively or non-invasively to patients who require Assisted/Control Mandatory Ventilation (A/CMV), Synchronized Intermittent Mandatory Ventilation (SIMV), or Spontaneous Ventilation (SPONT). The Nihon Kohden NKV-440 Ventilator System is intended to provide continuous ventilation for adult, pediatric and neonatal patients who require invasive or non-invasive 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.