FDA 510(k)

NOxBOXi 질산가스 전달 시스템

K-번호: K171696 · 2018-10-02

결정일2018-10-02

제품 코드MRN

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

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기기 요약

NOxBOXi Nitric Oxide Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Praxair Distribution, Inc.. It received FDA 510(k) clearance on 2018-10-02 under 510(k) number K171696. The device is classified under product code MRN. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the NOxBOXi Nitric Oxide Delivery System?

NOxBOXi Nitric Oxide Delivery System is a medical device that received FDA 510(k) clearance on 2018-10-02. The listed applicant is Praxair Distribution, Inc.. The 510(k) number is K171696.

When did NOxBOXi Nitric Oxide Delivery System receive FDA 510(k) clearance?

NOxBOXi Nitric Oxide Delivery System received FDA 510(k) clearance on 2018-10-02, under 510(k) number K171696.

Who is the listed applicant for NOxBOXi Nitric Oxide Delivery System?

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

What is the FDA product code for NOxBOXi Nitric Oxide Delivery System?

The FDA product code for NOxBOXi Nitric Oxide Delivery System is MRN.

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NOxBOXi 질산가스 전달 시스템

기기 요약

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관련 임상시험

관련 기기 (코드: MRN)

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