FDA 510(k)

Remunity 系統

K 號：K243354 · 2024-11-27

決定日期2024-11-27

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

Remunity System is the device name listed in this FDA 510(k) record. The listed applicant is Deka Research & Development Corp.. It received FDA 510(k) clearance on 2024-11-27 under 510(k) number K243354. 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 Remunity System?

Remunity System is a medical device that received FDA 510(k) clearance on 2024-11-27. The listed applicant is Deka Research & Development Corp.. The 510(k) number is K243354.

When did Remunity System receive FDA 510(k) clearance?

Remunity System received FDA 510(k) clearance on 2024-11-27, under 510(k) number K243354.

Who is the listed applicant for Remunity System?

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

What is the FDA product code for Remunity System?

The FDA product code for Remunity System is QJY.

其他以 Deka Research & Development Corp. 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。

K250930twiist系統 K250357RemunityPRO™ 泵用於Remodulin®（treprostinil）注射劑 K241736Remunity 2.0 泵用於Remodulin（treprostinil）注射劑 K172601下一代iBOT

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。

K240256Remunity 系統Deka Research and Development K202690Remunity 泵用於Remodulin（treprostinil）注射劑Deka Research and Development K191313Unity 皮下单室輸注系統用於RemodulinDEKA Research & Development

官方來源

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