FDA 510(k)

DBLG2

Número K: K251152 · 2025-12-19

Data da decisão2025-12-19

Código do produtoQJI

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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