EV Insite 系統
K 號：K152716 · 2016-03-24
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器材摘要
EV Insite System is the device name listed in this FDA 510(k) record. The listed applicant is Psp Corporation. It received FDA 510(k) clearance on 2016-03-24 under 510(k) number K152716. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the EV Insite System?
EV Insite System is a medical device that received FDA 510(k) clearance on 2016-03-24. The listed applicant is Psp Corporation. The 510(k) number is K152716.
When did EV Insite System receive FDA 510(k) clearance?
EV Insite System received FDA 510(k) clearance on 2016-03-24, under 510(k) number K152716.
Who is the listed applicant for EV Insite System?
The FDA 510(k) record lists Psp Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EV Insite System?
The FDA product code for EV Insite System is LLZ.
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相關器械（代碼：LLZ）
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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