FDA 510(k)

산소 집중기, 모델 JAY-5AW

K-번호: K213210 · 2022-12-08

결정일2022-12-08

제품 코드CAW

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

Oxygen Concentrator, Model JAY-5AW is the device name listed in this FDA 510(k) record. The listed applicant is Longfian Scitech Co., Ltd.. It received FDA 510(k) clearance on 2022-12-08 under 510(k) number K213210. The device is classified under product code CAW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Oxygen Concentrator, Model JAY-5AW?

Oxygen Concentrator, Model JAY-5AW is a medical device that received FDA 510(k) clearance on 2022-12-08. The listed applicant is Longfian Scitech Co., Ltd.. The 510(k) number is K213210.

When did Oxygen Concentrator, Model JAY-5AW receive FDA 510(k) clearance?

Oxygen Concentrator, Model JAY-5AW received FDA 510(k) clearance on 2022-12-08, under 510(k) number K213210.

Who is the listed applicant for Oxygen Concentrator, Model JAY-5AW?

The FDA 510(k) record lists Longfian Scitech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Oxygen Concentrator, Model JAY-5AW?

The FDA product code for Oxygen Concentrator, Model JAY-5AW is CAW.

Longfian Scitech Co., Ltd.를 신청인으로 등재한 기타 기록

K243833포터블 산소 집중기 (JAY-1000P)

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