EpiAccess 系統
K 號：K170831 · 2017-05-09
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器材摘要
EpiAccess System is the device name listed in this FDA 510(k) record. The listed applicant is Epiep, Inc.. It received FDA 510(k) clearance on 2017-05-09 under 510(k) number K170831. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the EpiAccess System?
EpiAccess System is a medical device that received FDA 510(k) clearance on 2017-05-09. The listed applicant is Epiep, Inc.. The 510(k) number is K170831.
When did EpiAccess System receive FDA 510(k) clearance?
EpiAccess System received FDA 510(k) clearance on 2017-05-09, under 510(k) number K170831.
Who is the listed applicant for EpiAccess System?
The FDA 510(k) record lists Epiep, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EpiAccess System?
The FDA product code for EpiAccess System is DYB.
相關臨床試驗
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相關器械（代碼：DYB）
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
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