Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Walk-O2-Bout

K-Number: K161472 · 2016-11-18

ApplicantEssex Industries, Inc.
Decision Date2016-11-18
Product CodeECX
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Walk-O2-Bout is a medical device manufactured by Essex Industries, Inc.. It received FDA 510(k) clearance on 2016-11-18 under approval 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. It is manufactured by Essex Industries, Inc.. The 510(k) number is K161472.

When was Walk-O2-Bout approved by the FDA?

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

What company makes Walk-O2-Bout?

Walk-O2-Bout is manufactured by Essex Industries, Inc..

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

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

Other Devices by Essex Industries, Inc.

K162811MR Conditional CGA 870

Related Devices (Code: ECX)

K153518Medipure Oxygen-LC SystemPraxair Distribution, Incorporated. K161179Intelli-OxAir Liquide Healthcare America Corporation

Official Source

View on FDA Database →

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

↑