Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Nihon Kohden NKV-330 Ventilator System

K-Number: K213521 · 2022-07-01

ApplicantNihon Kohden Orangemed, Inc.
Decision Date2022-07-01
Product CodeMNT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Nihon Kohden NKV-330 Ventilator System is a medical device manufactured by Nihon Kohden Orangemed, Inc.. It received FDA 510(k) clearance on 2022-07-01 under approval number K213521. The device is classified under product code MNT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nihon Kohden NKV-330 Ventilator System?

Nihon Kohden NKV-330 Ventilator System is a medical device that received FDA 510(k) clearance on 2022-07-01. It is manufactured by Nihon Kohden Orangemed, Inc.. The 510(k) number is K213521.

When was Nihon Kohden NKV-330 Ventilator System approved by the FDA?

Nihon Kohden NKV-330 Ventilator System received FDA 510(k) clearance on 2022-07-01, under approval number K213521.

What company makes Nihon Kohden NKV-330 Ventilator System?

Nihon Kohden NKV-330 Ventilator System is manufactured by Nihon Kohden Orangemed, Inc..

What is the FDA product code for Nihon Kohden NKV-330 Ventilator System?

The FDA product code for Nihon Kohden NKV-330 Ventilator System is MNT.

Related Clinical Trials

NCT06595602 Intelligent Lung Support in the Intensive Care Unit RECRUITING

Other Devices by Nihon Kohden Orangemed, Inc.

K181695Nihon Kohden NKV-550 Series Ventilator System K192307Nihon Kohden NKV-550 Series Ventilator System K222644Nihon Kohden NKV-440 Ventilator System

Related Devices (Code: MNT)

K170367Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Extra SmallFisher and Paykel Healthcare Limited K191624F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve VersionFisher & Paykel Healthcare Limited K230173Servo-air Lite Ventilator SystemMaquet Critical Care AB K240779Vivo 3Breas Medical AB K233643F&P Airvo 3 NIV (PT311US)Fisher & Paykel Healthcare, Ltd. K242931HFT750UMekics Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑