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 the device name listed in this FDA 510(k) record. The listed applicant is Praxair Distribution, Incorporated.. It received FDA 510(k) clearance on 2016-06-03 under 510(k) 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. The listed applicant is Praxair Distribution, Incorporated.. The 510(k) number is K153518.

When did Medipure Oxygen-LC System receive FDA 510(k) clearance?

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

Who is the listed applicant for Medipure Oxygen-LC System?

The FDA 510(k) record lists Praxair Distribution, Incorporated. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Praxair Distribution, Incorporated. 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.

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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.