FDA 510(k)

氧气浓缩器-P2-O5E

K号: K251764 · 2025-12-22

申请人Qingdao Kingon Medical Science and Technology Co., Ltd.

决定日期2025-12-22

产品代码CAW

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决定实质等同

器械摘要

Oxygen Concentrator-P2-O5E 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 2025-12-22 under 510(k) number K251764. The device is classified under product code CAW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Oxygen Concentrator-P2-O5E?

Oxygen Concentrator-P2-O5E is a medical device that received FDA 510(k) clearance on 2025-12-22. The listed applicant is Qingdao Kingon Medical Science and Technology Co., Ltd.. The 510(k) number is K251764.

When did Oxygen Concentrator-P2-O5E receive FDA 510(k) clearance?

Oxygen Concentrator-P2-O5E received FDA 510(k) clearance on 2025-12-22, under 510(k) number K251764.

Who is the listed applicant for Oxygen Concentrator-P2-O5E?

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 Oxygen Concentrator-P2-O5E?

The FDA product code for Oxygen Concentrator-P2-O5E is CAW.

列明Qingdao Kingon Medical Science and Technology Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K242718便携式制氧机（P2-TOC）K230702便携式制氧机（型号：P2-S4, P2-S3,P2-K4,P2-K3）K223379便携式制氧机（型号：P2-E7, P2-E）K210371便携式制氧机，型号：P2-E6

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