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FDA 510(k)

APIERON INSIGHT ENO SYSTEM

K-Number: K083617 · 2009-01-27

ApplicantApieron, Inc.
Decision Date2009-01-27
Product CodeMXA
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

APIERON INSIGHT ENO SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Apieron, Inc.. It received FDA 510(k) clearance on 2009-01-27 under 510(k) number K083617. 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 APIERON INSIGHT ENO SYSTEM?

APIERON INSIGHT ENO SYSTEM is a medical device that received FDA 510(k) clearance on 2009-01-27. The listed applicant is Apieron, Inc.. The 510(k) number is K083617.

When did APIERON INSIGHT ENO SYSTEM receive FDA 510(k) clearance?

APIERON INSIGHT ENO SYSTEM received FDA 510(k) clearance on 2009-01-27, under 510(k) number K083617.

Who is the listed applicant for APIERON INSIGHT ENO SYSTEM?

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

What is the FDA product code for APIERON INSIGHT ENO SYSTEM?

The FDA product code for APIERON INSIGHT ENO SYSTEM 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 Apieron, Inc. 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.

K073265APIERON INSIGHT EXHALED NITRIC OXIDE (ENO) SYSTEM

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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