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FDA 510(k)

Nihon Kohden NKV-550 Series Ventilator System

K-Number: K231778 · 2024-03-01

ApplicantNihon Kohden Orangemed, LLC
Decision Date2024-03-01
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Nihon Kohden NKV-550 Series Ventilator System is a medical device manufactured by Nihon Kohden Orangemed, LLC. It received FDA 510(k) clearance on 2024-03-01 under approval number K231778. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nihon Kohden NKV-550 Series Ventilator System?

Nihon Kohden NKV-550 Series Ventilator System is a medical device that received FDA 510(k) clearance on 2024-03-01. It is manufactured by Nihon Kohden Orangemed, LLC. The 510(k) number is K231778.

When was Nihon Kohden NKV-550 Series Ventilator System approved by the FDA?

Nihon Kohden NKV-550 Series Ventilator System received FDA 510(k) clearance on 2024-03-01, under approval number K231778.

What company makes Nihon Kohden NKV-550 Series Ventilator System?

Nihon Kohden NKV-550 Series Ventilator System is manufactured by Nihon Kohden Orangemed, LLC.

What is the FDA product code for Nihon Kohden NKV-550 Series Ventilator System?

The FDA product code for Nihon Kohden NKV-550 Series Ventilator System is CBK.

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Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026)

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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.

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