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FDA 510(k)

Inogen Rove 4 輕便氧濃度濃縮器

K 號:K222086 · 2022-12-09

申請人Inogen
決定日期2022-12-09
產品代碼CAW
諮詢委員會AN
決定相當於

器材摘要

Inogen Rove 4 Portable Oxygen Concentrator is the device name listed in this FDA 510(k) record. The listed applicant is Inogen. It received FDA 510(k) clearance on 2022-12-09 under 510(k) number K222086. 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 Inogen Rove 4 Portable Oxygen Concentrator?

Inogen Rove 4 Portable Oxygen Concentrator is a medical device that received FDA 510(k) clearance on 2022-12-09. The listed applicant is Inogen. The 510(k) number is K222086.

When did Inogen Rove 4 Portable Oxygen Concentrator receive FDA 510(k) clearance?

Inogen Rove 4 Portable Oxygen Concentrator received FDA 510(k) clearance on 2022-12-09, under 510(k) number K222086.

Who is the listed applicant for Inogen Rove 4 Portable Oxygen Concentrator?

The FDA 510(k) record lists Inogen as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Inogen Rove 4 Portable Oxygen Concentrator?

The FDA product code for Inogen Rove 4 Portable Oxygen Concentrator is CAW.

相關臨床試驗

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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。

官方來源

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