Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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 the device name listed in this FDA 510(k) record. The listed applicant is Nihon Kohden Orangemed, Inc.. It received FDA 510(k) clearance on 2022-07-01 under 510(k) 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. The listed applicant is Nihon Kohden Orangemed, Inc.. The 510(k) number is K213521.

When did Nihon Kohden NKV-330 Ventilator System receive FDA 510(k) clearance?

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

Who is the listed applicant for Nihon Kohden NKV-330 Ventilator System?

The FDA 510(k) record lists Nihon Kohden Orangemed, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Nihon Kohden Orangemed, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231778Nihon Kohden NKV-550 Series Ventilator SystemK222644Nihon Kohden NKV-440 Ventilator SystemK192307Nihon Kohden NKV-550 Series Ventilator SystemK181695Nihon Kohden NKV-550 Series Ventilator System

Related Devices (Code: MNT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252182SV70 Ventilator (SV70)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.K242931HFT750UMekics Co., Ltd.K240779Vivo 3Breas Medical ABK233643F&P Airvo 3 NIV (PT311US)Fisher & Paykel Healthcare, Ltd.K230173Servo-air Lite Ventilator SystemMaquet Critical Care ABK191624F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve VersionFisher & Paykel Healthcare Limited

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.

↑