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FDA 510(k)

WaveSense Jazz Blood Glucose Monitoring System

N.º K: K241304 · 2024-06-06

SolicitanteAgamatrix
Fecha de decisión2024-06-06
Código de productoNBW
Comité asesorCH
DecisiónSubstantially Equivalent

Resumen del dispositivo

WaveSense Jazz Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Agamatrix. It received FDA 510(k) clearance on 2024-06-06 under 510(k) number K241304. 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 WaveSense Jazz Blood Glucose Monitoring System?

WaveSense Jazz Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2024-06-06. The listed applicant is Agamatrix. The 510(k) number is K241304.

When did WaveSense Jazz Blood Glucose Monitoring System receive FDA 510(k) clearance?

WaveSense Jazz Blood Glucose Monitoring System received FDA 510(k) clearance on 2024-06-06, under 510(k) number K241304.

Who is the listed applicant for WaveSense Jazz Blood Glucose Monitoring System?

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

What is the FDA product code for WaveSense Jazz Blood Glucose Monitoring System?

The FDA product code for WaveSense Jazz 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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