InSure ONE
K 號：K170548 · 2017-10-05
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器材摘要
InSure ONE is the device name listed in this FDA 510(k) record. The listed applicant is Enterix, Inc.. It received FDA 510(k) clearance on 2017-10-05 under 510(k) number K170548. The device is classified under product code KHE. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the InSure ONE?
InSure ONE is a medical device that received FDA 510(k) clearance on 2017-10-05. The listed applicant is Enterix, Inc.. The 510(k) number is K170548.
When did InSure ONE receive FDA 510(k) clearance?
InSure ONE received FDA 510(k) clearance on 2017-10-05, under 510(k) number K170548.
Who is the listed applicant for InSure ONE?
The FDA 510(k) record lists Enterix, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for InSure ONE?
The FDA product code for InSure ONE is KHE.
相關臨床試驗
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相關器械（代碼：KHE）
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。
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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