Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

NIOX VERO

K-Number: K170983 · 2017-11-22

ApplicantCircassia AB
Decision Date2017-11-22
Product CodeMXA
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

NIOX VERO is a medical device manufactured by Circassia AB. It received FDA 510(k) clearance on 2017-11-22 under approval number K170983. The device is classified under product code MXA. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NIOX VERO?

NIOX VERO is a medical device that received FDA 510(k) clearance on 2017-11-22. It is manufactured by Circassia AB. The 510(k) number is K170983.

When was NIOX VERO approved by the FDA?

NIOX VERO received FDA 510(k) clearance on 2017-11-22, under approval number K170983.

What company makes NIOX VERO?

NIOX VERO is manufactured by Circassia AB.

What is the FDA product code for NIOX VERO?

The FDA product code for NIOX VERO is MXA.

Related Devices (Code: MXA)

K182874Fenom Pro Nitric Oxide TestSpirosure, Inc. K203695NObreath®Bedfont Scientific, Ltd. K213611Fenom ProCaire Diagnostics, Inc. K233775Vivatmo proBosch Healthcare Solutions GmbH K251674Fenom Flo™ FeNO Monitoring SystemMgc Diagnostics Corporation K243926Vivatmo pro-SBosch Healthcare Solutions GmbH

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.

↑