新生兒光療系統
K 號：K200031 · 2020-10-05
廣告
決定日期2020-10-05
產品代碼LBI
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
Neonatal Phototherapy System is the device name listed in this FDA 510(k) record. The listed applicant is Avalon Biomedical (Shenzhen) Limited. It received FDA 510(k) clearance on 2020-10-05 under 510(k) number K200031. The device is classified under product code LBI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Neonatal Phototherapy System?
Neonatal Phototherapy System is a medical device that received FDA 510(k) clearance on 2020-10-05. The listed applicant is Avalon Biomedical (Shenzhen) Limited. The 510(k) number is K200031.
When did Neonatal Phototherapy System receive FDA 510(k) clearance?
Neonatal Phototherapy System received FDA 510(k) clearance on 2020-10-05, under 510(k) number K200031.
Who is the listed applicant for Neonatal Phototherapy System?
The FDA 510(k) record lists Avalon Biomedical (Shenzhen) Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Neonatal Phototherapy System?
The FDA product code for Neonatal Phototherapy System is LBI.
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：LBI）
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。
廣告