Evita (V800)；Evita (V600)
K 號：K253647 · 2026-05-07
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器材摘要
Evita (V800); Evita (V600) is the device name listed in this FDA 510(k) record. The listed applicant is Draegerwerk AG & CO Kgaa. It received FDA 510(k) clearance on 2026-05-07 under 510(k) number K253647. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Evita (V800); Evita (V600)?
Evita (V800); Evita (V600) is a medical device that received FDA 510(k) clearance on 2026-05-07. The listed applicant is Draegerwerk AG & CO Kgaa. The 510(k) number is K253647.
When did Evita (V800); Evita (V600) receive FDA 510(k) clearance?
Evita (V800); Evita (V600) received FDA 510(k) clearance on 2026-05-07, under 510(k) number K253647.
Who is the listed applicant for Evita (V800); Evita (V600)?
The FDA 510(k) record lists Draegerwerk AG & CO Kgaa as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Evita (V800); Evita (V600)?
The FDA product code for Evita (V800); Evita (V600) is CBK.
相關臨床試驗
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其他以 Draegerwerk 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。
相關器械（代碼：CBK）
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
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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