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FDA 510(k)

On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System

N.º K: K181527 · 2018-10-03

SolicitanteACON Laboratories, Inc.
Fecha de decisión2018-10-03
Código de productoNBW
Comité asesorCH
DecisiónSubstantially Equivalent

Resumen del dispositivo

On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is ACON Laboratories, Inc.. It received FDA 510(k) clearance on 2018-10-03 under 510(k) number K181527. 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 On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System?

On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2018-10-03. The listed applicant is ACON Laboratories, Inc.. The 510(k) number is K181527.

When did On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System receive FDA 510(k) clearance?

On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System received FDA 510(k) clearance on 2018-10-03, under 510(k) number K181527.

Who is the listed applicant for On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System?

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

What is the FDA product code for On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System?

The FDA product code for On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.

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Otros registros que enlistan a ACON Laboratories, Inc. como solicitante

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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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