FDA 510(k)

DBLG2

K 號：K251152 · 2025-12-19

決定日期2025-12-19

產品代碼QJI

諮詢委員會CH

決定相當於

器材摘要

DBLG2 is the device name listed in this FDA 510(k) record. The listed applicant is Diabeloop. It received FDA 510(k) clearance on 2025-12-19 under 510(k) number K251152. The device is classified under product code QJI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DBLG2?

DBLG2 is a medical device that received FDA 510(k) clearance on 2025-12-19. The listed applicant is Diabeloop. The 510(k) number is K251152.

When did DBLG2 receive FDA 510(k) clearance?

DBLG2 received FDA 510(k) clearance on 2025-12-19, under 510(k) number K251152.

Who is the listed applicant for DBLG2?

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

What is the FDA product code for DBLG2?

The FDA product code for DBLG2 is QJI.

相關器械（代碼：QJI）

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官方來源

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