WAVE醫療平台（2.0.000）
K 號：K250135 · 2026-01-16
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器材摘要
WAVE Clinical Platform (2.0.000) is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp/ Excel Medical. It received FDA 510(k) clearance on 2026-01-16 under 510(k) number K250135. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the WAVE Clinical Platform (2.0.000)?
WAVE Clinical Platform (2.0.000) is a medical device that received FDA 510(k) clearance on 2026-01-16. The listed applicant is Baxter Healthcare Corp/ Excel Medical. The 510(k) number is K250135.
When did WAVE Clinical Platform (2.0.000) receive FDA 510(k) clearance?
WAVE Clinical Platform (2.0.000) received FDA 510(k) clearance on 2026-01-16, under 510(k) number K250135.
Who is the listed applicant for WAVE Clinical Platform (2.0.000)?
The FDA 510(k) record lists Baxter Healthcare Corp/ Excel Medical as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for WAVE Clinical Platform (2.0.000)?
The FDA product code for WAVE Clinical Platform (2.0.000) is MWI.
相關臨床試驗
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相關器械（代碼：MWI）
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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