啟明Vue 微內視系統
K 號：K192300 · 2020-03-20
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器材摘要
EnlightenVue Microendoscopy System is the device name listed in this FDA 510(k) record. The listed applicant is Enlightenvue, Inc.. It received FDA 510(k) clearance on 2020-03-20 under 510(k) number K192300. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the EnlightenVue Microendoscopy System?
EnlightenVue Microendoscopy System is a medical device that received FDA 510(k) clearance on 2020-03-20. The listed applicant is Enlightenvue, Inc.. The 510(k) number is K192300.
When did EnlightenVue Microendoscopy System receive FDA 510(k) clearance?
EnlightenVue Microendoscopy System received FDA 510(k) clearance on 2020-03-20, under 510(k) number K192300.
Who is the listed applicant for EnlightenVue Microendoscopy System?
The FDA 510(k) record lists Enlightenvue, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EnlightenVue Microendoscopy System?
The FDA product code for EnlightenVue Microendoscopy System is GCJ.
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相關器械（代碼：GCJ）
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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