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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 a medical device manufactured by Spirosure, Inc.. It received FDA 510(k) clearance on 2019-02-13 under approval 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. It is manufactured by Spirosure, Inc.. The 510(k) number is K182874.

When was Fenom Pro Nitric Oxide Test approved by the FDA?

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

What company makes Fenom Pro Nitric Oxide Test?

Fenom Pro Nitric Oxide Test is manufactured by Spirosure, Inc..

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

The FDA product code for Fenom Pro Nitric Oxide Test is MXA.

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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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