FDA 510(k)

Portable Oxygen Concentrator (P2-TOC)

K-번호: K242718 · 2025-02-28

신청자Qingdao Kingon Medical Science and Technology Co., Ltd.

결정일2025-02-28

제품 코드CAW

자문 위원회AN

결정Substantially Equivalent

기기 요약

Portable Oxygen Concentrator (P2-TOC) is the device name listed in this FDA 510(k) record. The listed applicant is Qingdao Kingon Medical Science and Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-02-28 under 510(k) number K242718. 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 Portable Oxygen Concentrator (P2-TOC)?

Portable Oxygen Concentrator (P2-TOC) is a medical device that received FDA 510(k) clearance on 2025-02-28. The listed applicant is Qingdao Kingon Medical Science and Technology Co., Ltd.. The 510(k) number is K242718.

When did Portable Oxygen Concentrator (P2-TOC) receive FDA 510(k) clearance?

Portable Oxygen Concentrator (P2-TOC) received FDA 510(k) clearance on 2025-02-28, under 510(k) number K242718.

Who is the listed applicant for Portable Oxygen Concentrator (P2-TOC)?

The FDA 510(k) record lists Qingdao Kingon Medical Science and Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Portable Oxygen Concentrator (P2-TOC)?

The FDA product code for Portable Oxygen Concentrator (P2-TOC) is CAW.

Qingdao Kingon Medical Science and Technology Co., Ltd.를 신청인으로 등재한 기타 기록

K251764Oxygen Concentrator-P2-O5E K230702Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3)K223379Portable Oxygen Concentrator (Model: P2-E7, P2-E)K210371Portable Oxygen Concentrator, model: P2-E6

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