FDA 510(k)

NIOX VERO

K-Number: K170983 · 2017-11-22

Decision Date2017-11-22

Product CodeMXA

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

NIOX VERO is the device name listed in this FDA 510(k) record. The listed applicant is Circassia AB. It received FDA 510(k) clearance on 2017-11-22 under 510(k) 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. The listed applicant is Circassia AB. The 510(k) number is K170983.

When did NIOX VERO receive FDA 510(k) clearance?

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

Who is the listed applicant for NIOX VERO?

The FDA 510(k) record lists Circassia AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NIOX VERO?

The FDA product code for NIOX VERO is MXA.

Related Devices (Code: MXA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.