FDA 510(k)

Walk-O2-Bout

K-Number: K161472 · 2016-11-18

Decision Date2016-11-18

Product CodeECX

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

Walk-O2-Bout is the device name listed in this FDA 510(k) record. The listed applicant is Essex Industries, Inc.. It received FDA 510(k) clearance on 2016-11-18 under 510(k) number K161472. 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 Walk-O2-Bout?

Walk-O2-Bout is a medical device that received FDA 510(k) clearance on 2016-11-18. The listed applicant is Essex Industries, Inc.. The 510(k) number is K161472.

When did Walk-O2-Bout receive FDA 510(k) clearance?

Walk-O2-Bout received FDA 510(k) clearance on 2016-11-18, under 510(k) number K161472.

Who is the listed applicant for Walk-O2-Bout?

The FDA 510(k) record lists Essex Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Walk-O2-Bout?

The FDA product code for Walk-O2-Bout is ECX.

Other records listing Essex Industries, Inc. 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.

K162811MR Conditional CGA 870

Related Devices (Code: ECX)

K161179Intelli-OxAir Liquide Healthcare America Corporation 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.