FDA 510(k)

embecta Insulin Delivery System

N.º K: K234027 · 2024-08-30

Fecha de decisión2024-08-30

Código de productoQFG

Comité asesorCH

DecisiónSubstantially Equivalent

Resumen del dispositivo

embecta Insulin Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Embecta Medical I, LLC. It received FDA 510(k) clearance on 2024-08-30 under 510(k) number K234027. The device is classified under product code QFG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the embecta Insulin Delivery System?

embecta Insulin Delivery System is a medical device that received FDA 510(k) clearance on 2024-08-30. The listed applicant is Embecta Medical I, LLC. The 510(k) number is K234027.

When did embecta Insulin Delivery System receive FDA 510(k) clearance?

embecta Insulin Delivery System received FDA 510(k) clearance on 2024-08-30, under 510(k) number K234027.

Who is the listed applicant for embecta Insulin Delivery System?

The FDA 510(k) record lists Embecta Medical I, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for embecta Insulin Delivery System?

The FDA product code for embecta Insulin Delivery System is QFG.

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Dispositivos relacionados (Código: QFG)

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Fuente oficial

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