FDA 510(k)

JLN-23XX 시리즈 파이스론 컴프레서 분말기(모델 JLN-2300AS, JLN-2301AS, JLN-2317AS 및 JLN-2320AS)

K-번호: K161586 · 2017-09-06

신청자Shenzhen Homed Medical Device Co., Ltd.

결정일2017-09-06

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

결정대체적으로 동일

기기 요약

The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Homed Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2017-09-06 under 510(k) number K161586. 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 The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS)?

The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS) is a medical device that received FDA 510(k) clearance on 2017-09-06. The listed applicant is Shenzhen Homed Medical Device Co., Ltd.. The 510(k) number is K161586.

When did The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS) receive FDA 510(k) clearance?

The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS) received FDA 510(k) clearance on 2017-09-06, under 510(k) number K161586.

Who is the listed applicant for The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS)?

The FDA 510(k) record lists Shenzhen Homed Medical Device Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS)?

The FDA product code for The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS) is CAF.

Shenzhen Homed Medical Device Co., Ltd.를 신청인으로 등재한 기타 기록

K252616포터블 산소 집중기 (JLO-190P)K212395압축기 Nebulizer K170886홈드 메시 분말기

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