FDA 510(k)

Fenom Pro 氧化氮測試

K 號：K182874 · 2019-02-13

決定日期2019-02-13

產品代碼MXA

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決定相當於

器材摘要

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.

常見問題

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.

相關器械（代碼：MXA）

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官方來源

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