FDA 510(k)

Intelli-Ox

K-Number: K161179 · 2017-04-13

ApplicantAir Liquide Healthcare America Corporation

Decision Date2017-04-13

Product CodeECX

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Air Liquide Healthcare America Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K153564PURE CRYOGEN

Related Devices (Code: ECX)

K161472Walk-O2-BoutEssex Industries, Inc.K153518Medipure Oxygen-LC SystemPraxair Distribution, Incorporated.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.