FDA 510(k)

T1D1

N.º K: K252104 · 2025-08-20

Fecha de decisión2025-08-20

Código de productoNDC

Comité asesorAN

DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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.

Otros registros que enlistan a Comerge AG como solicitante

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K230195Neo ADVISE software

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Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.