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FDA 510(k)

Nihon Kohden NKV-550 Series Ventilator System

K-Number: K192307 · 2020-01-10

ApplicantNihon Kohden Orangemed, Inc.
Decision Date2020-01-10
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Nihon Kohden NKV-550 Series Ventilator System is a medical device manufactured by Nihon Kohden Orangemed, Inc.. It received FDA 510(k) clearance on 2020-01-10 under approval number K192307. 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 2020-01-10. It is manufactured by Nihon Kohden Orangemed, Inc.. The 510(k) number is K192307.

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 2020-01-10, under approval number K192307.

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

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

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) PMID: 41251011 Effectivity of the Dehydrated Human Amnion/Chorion Membrane Allograft for Diabetic Foot Ulcers in Japan: A Case Series. International wound journal (2025)

Other Devices by Nihon Kohden Orangemed, Inc.

K181695Nihon Kohden NKV-550 Series Ventilator System K213521Nihon Kohden NKV-330 Ventilator System K222644Nihon Kohden NKV-440 Ventilator System

Related Devices (Code: CBK)

K153046HAMILTON-MR1Hamilton Medical AG K152068Astral 100/150Resmed, Ltd. K143035Flight 60 VentilatorFlight Medical Innovations , Ltd. K151252Puritan Bennett 840 Series Ventilator SystemCovidien LP K162738Puritan Bennett 980 Ventilator SystemCovidien K170037Breathe Technologies Life2000™ Ventilation SystemBreathe Technologies

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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