FDA 510(k)

DEKA ACE 泵系統

K 號：K213536 · 2023-07-25

決定日期2023-07-25

產品代碼QFG

諮詢委員會CH

決定相當於

器材摘要

DEKA ACE Pump System is the device name listed in this FDA 510(k) record. The listed applicant is Deka Research and Development. It received FDA 510(k) clearance on 2023-07-25 under 510(k) number K213536. The device is classified under product code QFG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DEKA ACE Pump System?

DEKA ACE Pump System is a medical device that received FDA 510(k) clearance on 2023-07-25. The listed applicant is Deka Research and Development. The 510(k) number is K213536.

When did DEKA ACE Pump System receive FDA 510(k) clearance?

DEKA ACE Pump System received FDA 510(k) clearance on 2023-07-25, under 510(k) number K213536.

Who is the listed applicant for DEKA ACE Pump System?

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

What is the FDA product code for DEKA ACE Pump System?

The FDA product code for DEKA ACE Pump System is QFG.

其他以 Deka Research and Development 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。

K261672twiist自動胰島素輸送（AID）系統 K261530iiSure 靜脈輸注套件 K243841斯巴達胰島素輸液器 K233557HemoCare 血液透析系統 K240920HemoCare Bicarbonate Concentrate Set (BCS)K240256Remunity 系統

查看所有 15 項裝置 →

相關器械（代碼：QFG）

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。

K260001薄荷ACE泵Beta Bionics, Inc.K261672twiist自動胰島素輸送（AID）系統Deka Research and Development K253976iLet ACE 泵Beta Bionics, Inc.K253743迷你美德Flex泵Medtronic Minimed, Inc.K253470MiniMed 780G 胰島素針筒 (MMT-1884)；MiniMed 780G 胰島素針筒組合包 (MMT-1894)Medtronic Minimed, Inc.K253074Tandem Mobi 胰島素針筒配互操作性技術Tandem Diabetes Care, Inc.

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。