FDA 510(k)

endo數位平台

K 號：K232722 · 2023-10-03

決定日期2023-10-03

產品代碼QCC

諮詢委員會CH

決定相當於

器材摘要

endo.digital Platform is the device name listed in this FDA 510(k) record. The listed applicant is DreaMed Diabetes, Ltd.. It received FDA 510(k) clearance on 2023-10-03 under 510(k) number K232722. The device is classified under product code QCC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the endo.digital Platform?

endo.digital Platform is a medical device that received FDA 510(k) clearance on 2023-10-03. The listed applicant is DreaMed Diabetes, Ltd.. The 510(k) number is K232722.

When did endo.digital Platform receive FDA 510(k) clearance?

endo.digital Platform received FDA 510(k) clearance on 2023-10-03, under 510(k) number K232722.

Who is the listed applicant for endo.digital Platform?

FDA 510(k) 記錄將 DreaMed Diabetes, Ltd. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for endo.digital Platform?

The FDA product code for endo.digital Platform is QCC.

其他以 DreaMed Diabetes, Ltd. 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。

K260062MODI系統 K210561Advisor Pro 平台 K201476DreaMed Advisor Pro K191370DreaMed Advisor Pro

相關器械（代碼：QCC）

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。

K210561Advisor Pro 平台DreaMed Diabetes, Ltd.K201476DreaMed Advisor ProDreaMed Diabetes, Ltd.K191370DreaMed Advisor ProDreaMed Diabetes, Ltd.

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。