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FDA 510(k)

Nuvo Nano Portable Oxygen Concentrator

K-Number: K192693 · 2020-05-07

ApplicantNidek Medical Products, Inc.
Decision Date2020-05-07
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Nuvo Nano Portable Oxygen Concentrator is a medical device manufactured by Nidek Medical Products, Inc.. It received FDA 510(k) clearance on 2020-05-07 under approval number K192693. The device is classified under product code CAW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nuvo Nano Portable Oxygen Concentrator?

Nuvo Nano Portable Oxygen Concentrator is a medical device that received FDA 510(k) clearance on 2020-05-07. It is manufactured by Nidek Medical Products, Inc.. The 510(k) number is K192693.

When was Nuvo Nano Portable Oxygen Concentrator approved by the FDA?

Nuvo Nano Portable Oxygen Concentrator received FDA 510(k) clearance on 2020-05-07, under approval number K192693.

What company makes Nuvo Nano Portable Oxygen Concentrator?

Nuvo Nano Portable Oxygen Concentrator is manufactured by Nidek Medical Products, Inc..

What is the FDA product code for Nuvo Nano Portable Oxygen Concentrator?

The FDA product code for Nuvo Nano Portable Oxygen Concentrator is CAW.

Related Clinical Trials

NCT06868979 Optical Imaging in X-linked Disorders. RECRUITING NCT07512687 Titrated Ambulatory Oxygen in Fibrotic ILD and COPD With Isolated Exertional Hypoxemia NOT_YET_RECRUITING

Related PubMed Literature

PMID: 34857221 Comparative study of a novel portable indirect calorimeter to a reference breath-by-breath instrument and its use in telemedicine settings. Clinical nutrition ESPEN (2021)

Related Devices (Code: CAW)

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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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