FDA 510(k)

便携式制氧机，型号：P2-E6

K号: K210371 · 2022-06-03

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

决定日期2022-06-03

产品代码CAW

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决定实质等同

器械摘要

Portable Oxygen Concentrator, model: P2-E6 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 2022-06-03 under 510(k) number K210371. 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 Portable Oxygen Concentrator, model: P2-E6?

Portable Oxygen Concentrator, model: P2-E6 is a medical device that received FDA 510(k) clearance on 2022-06-03. The listed applicant is Qingdao Kingon Medical Science and Technology Co., Ltd.. The 510(k) number is K210371.

When did Portable Oxygen Concentrator, model: P2-E6 receive FDA 510(k) clearance?

Portable Oxygen Concentrator, model: P2-E6 received FDA 510(k) clearance on 2022-06-03, under 510(k) number K210371.

Who is the listed applicant for Portable Oxygen Concentrator, model: P2-E6?

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, model: P2-E6?

The FDA product code for Portable Oxygen Concentrator, model: P2-E6 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。

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