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FDA 510(k)

Medipure Oxygen-LC System

K-Number: K153518 · 2016-06-03

ApplicantPraxair Distribution, Incorporated.
Decision Date2016-06-03
Product CodeECX
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Medipure Oxygen-LC System is a medical device manufactured by Praxair Distribution, Incorporated.. It received FDA 510(k) clearance on 2016-06-03 under approval number K153518. 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 Medipure Oxygen-LC System?

Medipure Oxygen-LC System is a medical device that received FDA 510(k) clearance on 2016-06-03. It is manufactured by Praxair Distribution, Incorporated.. The 510(k) number is K153518.

When was Medipure Oxygen-LC System approved by the FDA?

Medipure Oxygen-LC System received FDA 510(k) clearance on 2016-06-03, under approval number K153518.

What company makes Medipure Oxygen-LC System?

Medipure Oxygen-LC System is manufactured by Praxair Distribution, Incorporated..

What is the FDA product code for Medipure Oxygen-LC System?

The FDA product code for Medipure Oxygen-LC System is ECX.

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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.

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