FDA 510(k)

Intelli-Ox

K号: K161179 · 2017-04-13

申请人Air Liquide Healthcare America Corporation

决定日期2017-04-13

产品代码ECX

咨询委员会AN 请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。

决定实质等同

器械摘要

Intelli-Ox is the device name listed in this FDA 510(k) record. The listed applicant is Air Liquide Healthcare America Corporation. It received FDA 510(k) clearance on 2017-04-13 under 510(k) number K161179. The device is classified under product code ECX. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Intelli-Ox?

Intelli-Ox is a medical device that received FDA 510(k) clearance on 2017-04-13. The listed applicant is Air Liquide Healthcare America Corporation. The 510(k) number is K161179.

When did Intelli-Ox receive FDA 510(k) clearance?

Intelli-Ox received FDA 510(k) clearance on 2017-04-13, under 510(k) number K161179.

Who is the listed applicant for Intelli-Ox?

The FDA 510(k) record lists Air Liquide Healthcare America Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Intelli-Ox?

The FDA product code for Intelli-Ox is ECX.

列明Air Liquide Healthcare America Corporation为申报人的其他记录

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