ON-Q* 泵含鈕釋功能
K 號：K181360 · 2019-03-22
廣告
決定日期2019-03-22
產品代碼MEB
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
ON-Q* Pump with Bolus is the device name listed in this FDA 510(k) record. The listed applicant is Halyard Health. It received FDA 510(k) clearance on 2019-03-22 under 510(k) number K181360. The device is classified under product code MEB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the ON-Q* Pump with Bolus?
ON-Q* Pump with Bolus is a medical device that received FDA 510(k) clearance on 2019-03-22. The listed applicant is Halyard Health. The 510(k) number is K181360.
When did ON-Q* Pump with Bolus receive FDA 510(k) clearance?
ON-Q* Pump with Bolus received FDA 510(k) clearance on 2019-03-22, under 510(k) number K181360.
Who is the listed applicant for ON-Q* Pump with Bolus?
The FDA 510(k) record lists Halyard Health as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ON-Q* Pump with Bolus?
The FDA product code for ON-Q* Pump with Bolus is MEB.
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。
其他以 Halyard Health 為申請人之記錄
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：MEB）
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