FDA 510(k)

氧气浓缩器，型号 JAY-5AW

K号: K213210 · 2022-12-08

决定日期2022-12-08

产品代码CAW

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决定实质等同

器械摘要

Oxygen Concentrator, Model JAY-5AW is the device name listed in this FDA 510(k) record. The listed applicant is Longfian Scitech Co., Ltd.. It received FDA 510(k) clearance on 2022-12-08 under 510(k) number K213210. 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, Model JAY-5AW?

Oxygen Concentrator, Model JAY-5AW is a medical device that received FDA 510(k) clearance on 2022-12-08. The listed applicant is Longfian Scitech Co., Ltd.. The 510(k) number is K213210.

When did Oxygen Concentrator, Model JAY-5AW receive FDA 510(k) clearance?

Oxygen Concentrator, Model JAY-5AW received FDA 510(k) clearance on 2022-12-08, under 510(k) number K213210.

Who is the listed applicant for Oxygen Concentrator, Model JAY-5AW?

The FDA 510(k) record lists Longfian Scitech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Oxygen Concentrator, Model JAY-5AW?

The FDA product code for Oxygen Concentrator, Model JAY-5AW is CAW.

列明Longfian Scitech 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。

K243833便携式制氧机（JAY-1000P）

官方来源

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