FDA 510(k)

Hudson RCI AquaPak Sterile Prefilled Nebulizers

K-번호: K153010 · 2016-07-26

결정일2016-07-26

제품 코드CAF

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

Hudson RCI AquaPak Sterile Prefilled Nebulizers is the device name listed in this FDA 510(k) record. The listed applicant is Teleflexmedical, Inc.. It received FDA 510(k) clearance on 2016-07-26 under 510(k) number K153010. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Hudson RCI AquaPak Sterile Prefilled Nebulizers?

Hudson RCI AquaPak Sterile Prefilled Nebulizers is a medical device that received FDA 510(k) clearance on 2016-07-26. The listed applicant is Teleflexmedical, Inc.. The 510(k) number is K153010.

When did Hudson RCI AquaPak Sterile Prefilled Nebulizers receive FDA 510(k) clearance?

Hudson RCI AquaPak Sterile Prefilled Nebulizers received FDA 510(k) clearance on 2016-07-26, under 510(k) number K153010.

Who is the listed applicant for Hudson RCI AquaPak Sterile Prefilled Nebulizers?

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

What is the FDA product code for Hudson RCI AquaPak Sterile Prefilled Nebulizers?

The FDA product code for Hudson RCI AquaPak Sterile Prefilled Nebulizers is CAF.

Teleflexmedical, Inc.를 신청인으로 등재한 기타 기록

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