iPrime 粘度輸送系統
K 號：K212797 · 2022-01-06
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申請人Glaukos
決定日期2022-01-06
產品代碼MRH
諮詢委員會醫療設備規範文本翻譯如下：
HO
注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。
決定相當於
器材摘要
iPrime Viscodelivery System is the device name listed in this FDA 510(k) record. The listed applicant is Glaukos. It received FDA 510(k) clearance on 2022-01-06 under 510(k) number K212797. The device is classified under product code MRH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the iPrime Viscodelivery System?
iPrime Viscodelivery System is a medical device that received FDA 510(k) clearance on 2022-01-06. The listed applicant is Glaukos. The 510(k) number is K212797.
When did iPrime Viscodelivery System receive FDA 510(k) clearance?
iPrime Viscodelivery System received FDA 510(k) clearance on 2022-01-06, under 510(k) number K212797.
Who is the listed applicant for iPrime Viscodelivery System?
The FDA 510(k) record lists Glaukos as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for iPrime Viscodelivery System?
The FDA product code for iPrime Viscodelivery System is MRH.
相關臨床試驗
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。
相關器械（代碼：MRH）
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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