Singapore HSA registration DE0509453

Nihon Kohden NKV-440 Ventilator System

Singapore flagSingapore·CLASS C·Nihon Kohden OrangeMed, LLC·Registered June 25, 2024
Device classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0509453
Registration Date
June 25, 2024
Change Notification Approval Date
September 24, 2024
Retention Due Date
June 24, 2025
Product description
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.
Product Owner
Short Name
Nihon Kohden OrangeMed, LLC
Address
1800 E. Wilshire Avenue, Santa Ana, CA 92705, UNITED STATES
Registrant
Address
1 MARITIME SQUARE, HARBOURFRONT CENTRE, #10-34, SINGAPORE 099253
Importer
Address
1 MARITIME SQUARE, HARBOURFRONT CENTRE, #10-34, SINGAPORE 099253
Model information
Model Name(s)
NKV-440 Series Ventilator System NKV-440 Series Ventilator System
Model Identifier(s)
NKV-440 NKV-440 (with SpO2/CO2 option)
About this record

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.

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