FDA 510(k)

過濾 CareStar Plus，過濾 SafeStar Plus，過濾/HME TwinStar Plus

K 號：K221836 · 2022-12-07

決定日期2022-12-07

產品代碼CAH

諮詢委員會AN

決定相當於

器材摘要

Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus is the device name listed in this FDA 510(k) record. The listed applicant is Drägerwerk AG & Co. KGaA. It received FDA 510(k) clearance on 2022-12-07 under 510(k) number K221836. The device is classified under product code CAH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus?

Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus is a medical device that received FDA 510(k) clearance on 2022-12-07. The listed applicant is Drägerwerk AG & Co. KGaA. The 510(k) number is K221836.

When did Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus receive FDA 510(k) clearance?

Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus received FDA 510(k) clearance on 2022-12-07, under 510(k) number K221836.

Who is the listed applicant for Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus?

The FDA 510(k) record lists Drägerwerk AG & Co. KGaA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus?

The FDA product code for Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus is CAH.

其他以 Drägerwerk AG & Co. KGaA 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。

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相關器械（代碼：CAH）

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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