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FDA 510(k)

MEDICYL-E-LITE PORTABLE OXYGEN DELIVERY SYSTEM

K-Number: K033897 · 2004-07-19

ApplicantAga-Linde Health Care
Decision Date2004-07-19
Product CodeECX
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MEDICYL-E-LITE PORTABLE OXYGEN DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Aga-Linde Health Care. It received FDA 510(k) clearance on 2004-07-19 under 510(k) number K033897. 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 MEDICYL-E-LITE PORTABLE OXYGEN DELIVERY SYSTEM?

MEDICYL-E-LITE PORTABLE OXYGEN DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 2004-07-19. The listed applicant is Aga-Linde Health Care. The 510(k) number is K033897.

When did MEDICYL-E-LITE PORTABLE OXYGEN DELIVERY SYSTEM receive FDA 510(k) clearance?

MEDICYL-E-LITE PORTABLE OXYGEN DELIVERY SYSTEM received FDA 510(k) clearance on 2004-07-19, under 510(k) number K033897.

Who is the listed applicant for MEDICYL-E-LITE PORTABLE OXYGEN DELIVERY SYSTEM?

The FDA 510(k) record lists Aga-Linde Health Care as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDICYL-E-LITE PORTABLE OXYGEN DELIVERY SYSTEM?

The FDA product code for MEDICYL-E-LITE PORTABLE OXYGEN DELIVERY SYSTEM is ECX.

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Related Devices (Code: ECX)

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.

K161179Intelli-OxAir Liquide Healthcare America CorporationK161472Walk-O2-BoutEssex Industries, Inc.K153518Medipure Oxygen-LC SystemPraxair Distribution, Incorporated.K101792LIV LINDE INTERGRATED VALVE-PORTABLE OXYGEN SYSTEM, MODEL M706Linde Gas North America, LLCK063354LINDE INTEGRATED VALVE (LIV)Linde Gas TherapeuticsK062300OX-SOX, MODEL C, D, E,Pattient Safety Innovations, Llp

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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