FDA 510(k)

氧濃度濃縮器，型號 JAY-5AW

K 號：K213210 · 2022-12-08

決定日期2022-12-08

產品代碼CAW

諮詢委員會AN

決定相當於

器材摘要

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.

常見問題

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.

其他以 Longfian Scitech Co., Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K243833攜帶式氧氣濃縮機（JAY-1000P）

相關器械（代碼：CAW）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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