FDA 510(k)

Medipure Oxygen-LC System

K-번호: K153518 · 2016-06-03

결정일2016-06-03

제품 코드ECX

자문 위원회안내: 의료기기 규제 문서 번역 요청입니다. 회사명, 제품명, FDA, 510(k), PMA, NCT, PMID, 식별자 및 URL을 보존하여 번역하여 주세요. 정책: 의료규제-v1. [원문] AN [번역] 안내

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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.

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Medipure Oxygen-LC System

기기 요약

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관련 임상시험

관련 기기 (코드: ECX)

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