Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Fenom Pro Nitric Oxide Test

K-Number: K182874 · 2019-02-13

ApplicantSpirosure, Inc.
Decision Date2019-02-13
Product CodeMXA
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

Fenom Pro Nitric Oxide Test is the device name listed in this FDA 510(k) record. The listed applicant is Spirosure, Inc.. It received FDA 510(k) clearance on 2019-02-13 under 510(k) number K182874. 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 Fenom Pro Nitric Oxide Test?

Fenom Pro Nitric Oxide Test is a medical device that received FDA 510(k) clearance on 2019-02-13. The listed applicant is Spirosure, Inc.. The 510(k) number is K182874.

When did Fenom Pro Nitric Oxide Test receive FDA 510(k) clearance?

Fenom Pro Nitric Oxide Test received FDA 510(k) clearance on 2019-02-13, under 510(k) number K182874.

Who is the listed applicant for Fenom Pro Nitric Oxide Test?

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

What is the FDA product code for Fenom Pro Nitric Oxide Test?

The FDA product code for Fenom Pro Nitric Oxide Test 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.

NCT03445754Effect of Transcutaneous Vagal Stimulation (TVS) on Endothelial Function in PADCOMPLETED

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.K170983NIOX VEROCircassia AB

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.

↑