FDA 510(k)

Fenom Flo™ FeNO 監測系統

K 號：K251674 · 2025-11-26

決定日期2025-11-26

產品代碼MXA

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決定相當於

器材摘要

Fenom Flo™ FeNO Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Mgc Diagnostics Corporation. It received FDA 510(k) clearance on 2025-11-26 under 510(k) number K251674. 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 Flo™ FeNO Monitoring System?

Fenom Flo™ FeNO Monitoring System is a medical device that received FDA 510(k) clearance on 2025-11-26. The listed applicant is Mgc Diagnostics Corporation. The 510(k) number is K251674.

When did Fenom Flo™ FeNO Monitoring System receive FDA 510(k) clearance?

Fenom Flo™ FeNO Monitoring System received FDA 510(k) clearance on 2025-11-26, under 510(k) number K251674.

Who is the listed applicant for Fenom Flo™ FeNO Monitoring System?

The FDA 510(k) record lists Mgc Diagnostics Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fenom Flo™ FeNO Monitoring System?

The FDA product code for Fenom Flo™ FeNO Monitoring System is MXA.

相關器械（代碼：MXA）

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官方來源

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