NIOX VERO
K号: K170983 · 2017-11-22
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申请人Circassia AB
决定日期2017-11-22
产品代码MXA
咨询委员会TX
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决定实质等同
器械摘要
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.
常见问题
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.
相关器械（代码：MXA）
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官方来源
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