FDA 510(k)

OxyGo Portable Oxygen Concentrator (1400-7000)

K-번호: K252407 · 2026-04-23

결정일2026-04-23

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

결정Substantially Equivalent

기기 요약

OxyGo Portable Oxygen Concentrator (1400-7000) is the device name listed in this FDA 510(k) record. The listed applicant is Mv Life, LLC. It received FDA 510(k) clearance on 2026-04-23 under 510(k) number K252407. 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 OxyGo Portable Oxygen Concentrator (1400-7000)?

OxyGo Portable Oxygen Concentrator (1400-7000) is a medical device that received FDA 510(k) clearance on 2026-04-23. The listed applicant is Mv Life, LLC. The 510(k) number is K252407.

When did OxyGo Portable Oxygen Concentrator (1400-7000) receive FDA 510(k) clearance?

OxyGo Portable Oxygen Concentrator (1400-7000) received FDA 510(k) clearance on 2026-04-23, under 510(k) number K252407.

Who is the listed applicant for OxyGo Portable Oxygen Concentrator (1400-7000)?

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

What is the FDA product code for OxyGo Portable Oxygen Concentrator (1400-7000)?

The FDA product code for OxyGo Portable Oxygen Concentrator (1400-7000) is CAW.

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OxyGo Portable Oxygen Concentrator (1400-7000)

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: CAW)

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