Soteria 床邊防墜護具
K 號：K201876 · 2022-09-01
廣告
決定日期2022-09-01
產品代碼QTV
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
Soteria Bed Barrier is the device name listed in this FDA 510(k) record. The listed applicant is Trinity Guardion. It received FDA 510(k) clearance on 2022-09-01 under 510(k) number K201876. The device is classified under product code QTV. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Soteria Bed Barrier?
Soteria Bed Barrier is a medical device that received FDA 510(k) clearance on 2022-09-01. The listed applicant is Trinity Guardion. The 510(k) number is K201876.
When did Soteria Bed Barrier receive FDA 510(k) clearance?
Soteria Bed Barrier received FDA 510(k) clearance on 2022-09-01, under 510(k) number K201876.
Who is the listed applicant for Soteria Bed Barrier?
The FDA 510(k) record lists Trinity Guardion as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Soteria Bed Barrier?
The FDA product code for Soteria Bed Barrier is QTV.
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。
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