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FDA 510(k)

GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose Monitoring System

N.º K: K193340 · 2020-09-11

SolicitanteMicrotech Medical, Inc.
Fecha de decisión2020-09-11
Código de productoNBW
Comité asesorCH
DecisiónSubstantially Equivalent

Resumen del dispositivo

GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Microtech Medical, Inc.. It received FDA 510(k) clearance on 2020-09-11 under 510(k) number K193340. 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 GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose Monitoring System?

GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2020-09-11. The listed applicant is Microtech Medical, Inc.. The 510(k) number is K193340.

When did GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose Monitoring System receive FDA 510(k) clearance?

GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose Monitoring System received FDA 510(k) clearance on 2020-09-11, under 510(k) number K193340.

Who is the listed applicant for GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose Monitoring System?

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

What is the FDA product code for GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose Monitoring System?

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

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Dispositivos relacionados (Código: NBW)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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