FDA 510(k)

Sistema de Monitoreo de Glucosa en Sangre ActiveCare TD-4121

N.º K: K173511 · 2018-07-12

SolicitanteTaidoc Technology Corporation

Fecha de decisión2018-07-12

Código de productoNBW

Comité asesorCH

DecisiónSubstantially Equivalent

Resumen del dispositivo

ActiveCare TD-4121 Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Taidoc Technology Corporation. It received FDA 510(k) clearance on 2018-07-12 under 510(k) number K173511. 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 ActiveCare TD-4121 Blood Glucose Monitoring System?

ActiveCare TD-4121 Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2018-07-12. The listed applicant is Taidoc Technology Corporation. The 510(k) number is K173511.

When did ActiveCare TD-4121 Blood Glucose Monitoring System receive FDA 510(k) clearance?

ActiveCare TD-4121 Blood Glucose Monitoring System received FDA 510(k) clearance on 2018-07-12, under 510(k) number K173511.

Who is the listed applicant for ActiveCare TD-4121 Blood Glucose Monitoring System?

The FDA 510(k) record lists Taidoc Technology Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ActiveCare TD-4121 Blood Glucose Monitoring System?

The FDA product code for ActiveCare TD-4121 Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.

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Fuente oficial

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