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FDA 510(k)

NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR

K-Number: K123683 · 2012-12-27

ApplicantAerocrine AB
Decision Date2012-12-27
Product CodeMXA
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Aerocrine AB. It received FDA 510(k) clearance on 2012-12-27 under 510(k) number K123683. 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 PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR?

NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR is a medical device that received FDA 510(k) clearance on 2012-12-27. The listed applicant is Aerocrine AB. The 510(k) number is K123683.

When did NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR receive FDA 510(k) clearance?

NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR received FDA 510(k) clearance on 2012-12-27, under 510(k) number K123683.

Who is the listed applicant for NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR?

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

What is the FDA product code for NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR?

The FDA product code for NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR is MXA.

Related Clinical Trials

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.

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Other records listing Aerocrine AB as applicant

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.

K101034NIOX MINO MODEL 09-1000K072816NIOX MINO

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 CorporationK243926Vivatmo pro-SBosch Healthcare Solutions GmbHK233775Vivatmo proBosch Healthcare Solutions GmbHK213611Fenom 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.

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