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FDA 510(k)

NIOX MINO MODEL 09-1000

K-Number: K101034 · 2010-09-02

ApplicantAerocrine AB
Decision Date2010-09-02
Product CodeMXA
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

NIOX MINO MODEL 09-1000 is the device name listed in this FDA 510(k) record. The listed applicant is Aerocrine AB. It received FDA 510(k) clearance on 2010-09-02 under 510(k) number K101034. 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 MINO MODEL 09-1000?

NIOX MINO MODEL 09-1000 is a medical device that received FDA 510(k) clearance on 2010-09-02. The listed applicant is Aerocrine AB. The 510(k) number is K101034.

When did NIOX MINO MODEL 09-1000 receive FDA 510(k) clearance?

NIOX MINO MODEL 09-1000 received FDA 510(k) clearance on 2010-09-02, under 510(k) number K101034.

Who is the listed applicant for NIOX MINO MODEL 09-1000?

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 MINO MODEL 09-1000?

The FDA product code for NIOX MINO MODEL 09-1000 is MXA.

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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.

K123683NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITORK072816NIOX 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

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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