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FDA 510(k)

APIERON INSIGHT EXHALED NITRIC OXIDE (ENO) SYSTEM

K-Number: K073265 · 2008-03-14

ApplicantApieron, Inc.
Decision Date2008-03-14
Product CodeMXA
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

APIERON INSIGHT EXHALED NITRIC OXIDE (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 2008-03-14 under 510(k) number K073265. 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 EXHALED NITRIC OXIDE (ENO) SYSTEM?

APIERON INSIGHT EXHALED NITRIC OXIDE (ENO) SYSTEM is a medical device that received FDA 510(k) clearance on 2008-03-14. The listed applicant is Apieron, Inc.. The 510(k) number is K073265.

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

APIERON INSIGHT EXHALED NITRIC OXIDE (ENO) SYSTEM received FDA 510(k) clearance on 2008-03-14, under 510(k) number K073265.

Who is the listed applicant for APIERON INSIGHT EXHALED NITRIC OXIDE (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 EXHALED NITRIC OXIDE (ENO) SYSTEM?

The FDA product code for APIERON INSIGHT EXHALED NITRIC OXIDE (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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K083617APIERON INSIGHT 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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