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FDA 510(k)

BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System

N.º K: K160365 · 2016-09-28

SolicitanteInfopia Co, Ltd.
Fecha de decisión2016-09-28
Código de productoNBW
Comité asesorCH
DecisiónSubstantially Equivalent

Resumen del dispositivo

BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Infopia Co, Ltd.. It received FDA 510(k) clearance on 2016-09-28 under 510(k) number K160365. 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 BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System?

BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2016-09-28. The listed applicant is Infopia Co, Ltd.. The 510(k) number is K160365.

When did BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System receive FDA 510(k) clearance?

BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System received FDA 510(k) clearance on 2016-09-28, under 510(k) number K160365.

Who is the listed applicant for BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System?

The FDA 510(k) record lists Infopia Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System?

The FDA product code for BLE Smart Blood Glucose Monitoring System, BLE Smart Professional 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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