Nihon Kohden NKV-440 Ventilator System
K-Number: K222644 · 2023-05-31
ApplicantNihon Kohden Orangemed, Inc.
Decision Date2023-05-31
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
Nihon Kohden NKV-440 Ventilator System is a medical device manufactured by Nihon Kohden Orangemed, Inc.. It received FDA 510(k) clearance on 2023-05-31 under approval number K222644. 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-440 Ventilator System?
Nihon Kohden NKV-440 Ventilator System is a medical device that received FDA 510(k) clearance on 2023-05-31. It is manufactured by Nihon Kohden Orangemed, Inc.. The 510(k) number is K222644.
When was Nihon Kohden NKV-440 Ventilator System approved by the FDA?
Nihon Kohden NKV-440 Ventilator System received FDA 510(k) clearance on 2023-05-31, under approval number K222644.
What company makes Nihon Kohden NKV-440 Ventilator System?
Nihon Kohden NKV-440 Ventilator System is manufactured by Nihon Kohden Orangemed, Inc..
What is the FDA product code for Nihon Kohden NKV-440 Ventilator System?
The FDA product code for Nihon Kohden NKV-440 Ventilator System is CBK.
Related Clinical Trials
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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.