FDA 510(k)

GLUCOCARD® W onyx Blood Glucose Monitoring System

N.º K: K183306 · 2019-04-10

Fecha de decisión2019-04-10

Código de productoNBW

Comité asesorCH

DecisiónSubstantially Equivalent

Resumen del dispositivo

GLUCOCARD® W onyx Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Arkray Factory, Inc.. It received FDA 510(k) clearance on 2019-04-10 under 510(k) number K183306. 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 GLUCOCARD® W onyx Blood Glucose Monitoring System?

GLUCOCARD® W onyx Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2019-04-10. The listed applicant is Arkray Factory, Inc.. The 510(k) number is K183306.

When did GLUCOCARD® W onyx Blood Glucose Monitoring System receive FDA 510(k) clearance?

GLUCOCARD® W onyx Blood Glucose Monitoring System received FDA 510(k) clearance on 2019-04-10, under 510(k) number K183306.

Who is the listed applicant for GLUCOCARD® W onyx Blood Glucose Monitoring System?

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

What is the FDA product code for GLUCOCARD® W onyx Blood Glucose Monitoring System?

The FDA product code for GLUCOCARD® W onyx Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.

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Otros registros que enlistan a Arkray Factory, Inc. como solicitante

K170064GLUCOCARD W Blood Glucose Monitoring System K162822ADAMS A1c HA-8180V, CALIBRADOR 80

Dispositivos relacionados (Código: NBW)

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Fuente oficial

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