FDA 510(k)

FreeStyle Libre 3 Continuous Glucose Monitoring System

N.º K: K212132 · 2022-05-26

Fecha de decisión2022-05-26

Código de productoQLG

Comité asesorCH

DecisiónSubstantially Equivalent

Resumen del dispositivo

FreeStyle Libre 3 Continuous Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Diabetes Care, Inc.. It received FDA 510(k) clearance on 2022-05-26 under 510(k) number K212132. The device is classified under product code QLG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the FreeStyle Libre 3 Continuous Glucose Monitoring System?

FreeStyle Libre 3 Continuous Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2022-05-26. The listed applicant is Abbott Diabetes Care, Inc.. The 510(k) number is K212132.

When did FreeStyle Libre 3 Continuous Glucose Monitoring System receive FDA 510(k) clearance?

FreeStyle Libre 3 Continuous Glucose Monitoring System received FDA 510(k) clearance on 2022-05-26, under 510(k) number K212132.

Who is the listed applicant for FreeStyle Libre 3 Continuous Glucose Monitoring System?

The FDA 510(k) record lists Abbott Diabetes Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FreeStyle Libre 3 Continuous Glucose Monitoring System?

The FDA product code for FreeStyle Libre 3 Continuous Glucose Monitoring System is QLG.

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Otros registros que enlistan a Abbott Diabetes Care, Inc. como solicitante

K233537FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System K223435FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System K222447FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System K223537FreeStyle Libre 2 System, FreeStyle Libre 3 System K213996FreeStyle Libre 3 Continuous Glucose Monitoring System K210943FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)

Ver todos los 12 dispositivos →

Dispositivos relacionados (Código: QLG)

K222280Bigfoot Unity® Diabetes Management SystemBigfoot Biomedical, Inc.K223537FreeStyle Libre 2 System, FreeStyle Libre 3 SystemAbbott Diabetes Care, Inc.K213996FreeStyle Libre 3 Continuous Glucose Monitoring SystemAbbott Diabetes Care, Inc.K210943FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)Abbott Diabetes Care, Inc.K211102FreeStyle Libre 2 Flash Glucose Monitoring SystemAbbott Diabetes Care, Inc.K201761FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)Abbott Diabetes Care, Inc.

Fuente oficial

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