FDA 510(k)

Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System

N.º K: K160430 · 2016-06-24

SolicitanteAscensia Diabetes Care U.S., Inc.

Fecha de decisión2016-06-24

Código de productoNBW

Comité asesorCH

DecisiónSubstantially Equivalent

Resumen del dispositivo

Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next 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 2016-06-24 under 510(k) number K160430. 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 Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System?

Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2016-06-24. The listed applicant is Ascensia Diabetes Care U.S., Inc.. The 510(k) number is K160430.

When did Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System receive FDA 510(k) clearance?

Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System received FDA 510(k) clearance on 2016-06-24, under 510(k) number K160430.

Who is the listed applicant for Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next 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 Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System?

The FDA product code for Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next 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

K250813MICROLET®NEXT 2 Lancing Device K241787CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System K241810MICROLET®NEXT Lancet K223293CONTOUR® NEXT GEN Blood Glucose Monitoring System K220633MICROLET NEXT lancing device, MICROLET Lancet K162336Contour Next EZ Blood Glucose Monitoring System

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Dispositivos relacionados (Código: NBW)

K260545CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care K262116TRUE METRIX Self Monitoring Blood Glucose SystemTrividia Health, Inc.K250085On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring SystemACON Laboratories, Inc.K243060TeleRPM Gen2 Blood Glucose Monitoring SystemGuangdong Transtek Medical Electronics Co., Ltd.K240637RIGHTEST Blood Glucose Monitoring System Max TelBionime Corporation K240640Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring SystemSejoy Biomedical Co., Ltd.

Fuente oficial

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