靜脈壓監測系統
K 號：K183634 · 2019-04-17
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器材摘要
Stasis Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Stasis Labs, Inc.. It received FDA 510(k) clearance on 2019-04-17 under 510(k) number K183634. 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 Stasis Monitoring System?
Stasis Monitoring System is a medical device that received FDA 510(k) clearance on 2019-04-17. The listed applicant is Stasis Labs, Inc.. The 510(k) number is K183634.
When did Stasis Monitoring System receive FDA 510(k) clearance?
Stasis Monitoring System received FDA 510(k) clearance on 2019-04-17, under 510(k) number K183634.
Who is the listed applicant for Stasis Monitoring System?
The FDA 510(k) record lists Stasis Labs, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Stasis Monitoring System?
The FDA product code for Stasis Monitoring System 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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