FDA 510(k)

NIOX VERO

K 號：K170983 · 2017-11-22

決定日期2017-11-22

產品代碼MXA

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決定相當於

器材摘要

NIOX VERO is the device name listed in this FDA 510(k) record. The listed applicant is Circassia AB. It received FDA 510(k) clearance on 2017-11-22 under 510(k) number K170983. 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 NIOX VERO?

NIOX VERO is a medical device that received FDA 510(k) clearance on 2017-11-22. The listed applicant is Circassia AB. The 510(k) number is K170983.

When did NIOX VERO receive FDA 510(k) clearance?

NIOX VERO received FDA 510(k) clearance on 2017-11-22, under 510(k) number K170983.

Who is the listed applicant for NIOX VERO?

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

What is the FDA product code for NIOX VERO?

The FDA product code for NIOX VERO is MXA.

相關器械（代碼：MXA）

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