FDA 510(k)

T1D1

K 號：K252104 · 2025-08-20

決定日期2025-08-20

產品代碼NDC

諮詢委員會AN

決定相當於

器材摘要

T1D1 is the device name listed in this FDA 510(k) record. The listed applicant is Comerge AG. It received FDA 510(k) clearance on 2025-08-20 under 510(k) number K252104. The device is classified under product code NDC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the T1D1?

T1D1 is a medical device that received FDA 510(k) clearance on 2025-08-20. The listed applicant is Comerge AG. The 510(k) number is K252104.

When did T1D1 receive FDA 510(k) clearance?

T1D1 received FDA 510(k) clearance on 2025-08-20, under 510(k) number K252104.

Who is the listed applicant for T1D1?

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

What is the FDA product code for T1D1?

The FDA product code for T1D1 is NDC.

其他以 Comerge AG 為申請人之記錄

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K230195Neo 先進軟體

相關器械（代碼：NDC）

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。

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官方來源

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