FDA 510(k)

GlucoSure Link Blood Glucose Monitoring System

N.º K: K212140 · 2022-08-25

Fecha de decisión2022-08-25

Código de productoNBW

Comité asesorCH

DecisiónSubstantially Equivalent

Resumen del dispositivo

GlucoSure Link Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Apex BioTechnology Corp.. It received FDA 510(k) clearance on 2022-08-25 under 510(k) number K212140. 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 GlucoSure Link Blood Glucose Monitoring System?

GlucoSure Link Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2022-08-25. The listed applicant is Apex BioTechnology Corp.. The 510(k) number is K212140.

When did GlucoSure Link Blood Glucose Monitoring System receive FDA 510(k) clearance?

GlucoSure Link Blood Glucose Monitoring System received FDA 510(k) clearance on 2022-08-25, under 510(k) number K212140.

Who is the listed applicant for GlucoSure Link Blood Glucose Monitoring System?

The FDA 510(k) record lists Apex BioTechnology Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GlucoSure Link Blood Glucose Monitoring System?

The FDA product code for GlucoSure Link Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.

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Otros registros que enlistan a Apex BioTechnology Corp. como solicitante

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