FDA 510(k)

Omnipod 5 ACE 泵

K 號：K231826 · 2023-10-18

決定日期2023-10-18

產品代碼QFG

諮詢委員會CH

決定相當於

器材摘要

Omnipod 5 ACE Pump is the device name listed in this FDA 510(k) record. The listed applicant is Insulet Corporation. It received FDA 510(k) clearance on 2023-10-18 under 510(k) number K231826. 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 Omnipod 5 ACE Pump?

Omnipod 5 ACE Pump is a medical device that received FDA 510(k) clearance on 2023-10-18. The listed applicant is Insulet Corporation. The 510(k) number is K231826.

When did Omnipod 5 ACE Pump receive FDA 510(k) clearance?

Omnipod 5 ACE Pump received FDA 510(k) clearance on 2023-10-18, under 510(k) number K231826.

Who is the listed applicant for Omnipod 5 ACE Pump?

The FDA 510(k) record lists Insulet Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Omnipod 5 ACE Pump?

The FDA product code for Omnipod 5 ACE Pump is QFG.

其他以 Insulet Corporation 為申請人之記錄

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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

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