FDA 510(k)

CONTOUR® NEXT GEN Blood Glucose Monitoring System

N.º K: K223293 · 2022-11-18

SolicitanteAscensia Diabetes Care U.S., Inc.

Fecha de decisión2022-11-18

Código de productoNBW

Comité asesorCH

DecisiónSubstantially Equivalent

Resumen del dispositivo

CONTOUR® NEXT GEN Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Ascensia Diabetes Care U.S., Inc.. It received FDA 510(k) clearance on 2022-11-18 under 510(k) number K223293. The device is classified under product code NBW. It was reviewed by the CH advisory panel. Product code NBW falls under the category of OB/GYN, which includes obstetric and gynecological diagnostic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the CONTOUR® NEXT GEN Blood Glucose Monitoring System?

CONTOUR® NEXT GEN Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2022-11-18. The listed applicant is Ascensia Diabetes Care U.S., Inc.. The 510(k) number is K223293.

When did CONTOUR® NEXT GEN Blood Glucose Monitoring System receive FDA 510(k) clearance?

CONTOUR® NEXT GEN Blood Glucose Monitoring System received FDA 510(k) clearance on 2022-11-18, under 510(k) number K223293.

Who is the listed applicant for CONTOUR® NEXT GEN Blood Glucose Monitoring System?

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

What is the FDA product code for CONTOUR® NEXT GEN Blood Glucose Monitoring System?

The FDA product code for CONTOUR® NEXT GEN Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.

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Otros registros que enlistan a Ascensia Diabetes Care U.S., Inc. como solicitante

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Dispositivos relacionados (Código: NBW)

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Fuente oficial

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