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FDA 510(k)

Biolinq Shine Autonomous Time-in-Range Microsensor

N.º K: K262599 · 2026-09-18

SolicitanteBiolinq Incorporated
Fecha de decisión2026-09-18
Código de productoSFU
Comité asesorCH
DecisiónSubstantially Equivalent

Resumen del dispositivo

Biolinq Shine Autonomous Time-in-Range Microsensor is the device name listed in this FDA 510(k) record. The listed applicant is Biolinq Incorporated. It received FDA 510(k) clearance on 2026-09-18 under 510(k) number K262599. The device is classified under product code SFU. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Biolinq Shine Autonomous Time-in-Range Microsensor?

Biolinq Shine Autonomous Time-in-Range Microsensor is a medical device that received FDA 510(k) clearance on 2026-09-18. The listed applicant is Biolinq Incorporated. The 510(k) number is K262599.

When did Biolinq Shine Autonomous Time-in-Range Microsensor receive FDA 510(k) clearance?

Biolinq Shine Autonomous Time-in-Range Microsensor received FDA 510(k) clearance on 2026-09-18, under 510(k) number K262599.

Who is the listed applicant for Biolinq Shine Autonomous Time-in-Range Microsensor?

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

What is the FDA product code for Biolinq Shine Autonomous Time-in-Range Microsensor?

The FDA product code for Biolinq Shine Autonomous Time-in-Range Microsensor is SFU.

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