FDA 510(k)

Unity 皮下单室輸注系統用於Remodulin

K 號：K191313 · 2020-02-21

決定日期2020-02-21

產品代碼QJY

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

Unity Subcutaneous Infusion System for Remodulin is the device name listed in this FDA 510(k) record. The listed applicant is DEKA Research & Development. It received FDA 510(k) clearance on 2020-02-21 under 510(k) number K191313. The device is classified under product code QJY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Unity Subcutaneous Infusion System for Remodulin?

Unity Subcutaneous Infusion System for Remodulin is a medical device that received FDA 510(k) clearance on 2020-02-21. The listed applicant is DEKA Research & Development. The 510(k) number is K191313.

When did Unity Subcutaneous Infusion System for Remodulin receive FDA 510(k) clearance?

Unity Subcutaneous Infusion System for Remodulin received FDA 510(k) clearance on 2020-02-21, under 510(k) number K191313.

Who is the listed applicant for Unity Subcutaneous Infusion System for Remodulin?

The FDA 510(k) record lists DEKA Research & Development as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Unity Subcutaneous Infusion System for Remodulin?

The FDA product code for Unity Subcutaneous Infusion System for Remodulin is QJY.

其他以 DEKA Research & Development 為申請人之記錄

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相關器械（代碼：QJY）

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。

K243354Remunity 系統Deka Research & Development Corp.K240256Remunity 系統Deka Research and Development K202690Remunity 泵用於Remodulin（treprostinil）注射劑Deka Research and Development

官方來源

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