AK 98 腎透析機 (955607)
K 號：K250508 · 2025-08-01
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器材摘要
AK 98 Dialysis Machine (955607) is the device name listed in this FDA 510(k) record. The listed applicant is Vantive US Healthcare, LLC. It received FDA 510(k) clearance on 2025-08-01 under 510(k) number K250508. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the AK 98 Dialysis Machine (955607)?
AK 98 Dialysis Machine (955607) is a medical device that received FDA 510(k) clearance on 2025-08-01. The listed applicant is Vantive US Healthcare, LLC. The 510(k) number is K250508.
When did AK 98 Dialysis Machine (955607) receive FDA 510(k) clearance?
AK 98 Dialysis Machine (955607) received FDA 510(k) clearance on 2025-08-01, under 510(k) number K250508.
Who is the listed applicant for AK 98 Dialysis Machine (955607)?
The FDA 510(k) record lists Vantive US Healthcare, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AK 98 Dialysis Machine (955607)?
The FDA product code for AK 98 Dialysis Machine (955607) is KDI.
相關臨床試驗
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相關器械（代碼：KDI）
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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