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FDA 510(k)

TRUENESS™ AIR Blood Glucose Monitoring System; TRUENESS™ Blood Glucose Monitoring System

N.º K: K231476 · 2023-12-01

SolicitanteSinocare, Inc.
Fecha de decisión2023-12-01
Código de productoNBW
Comité asesorCH
DecisiónSubstantially Equivalent

Resumen del dispositivo

TRUENESS™ AIR Blood Glucose Monitoring System; TRUENESS™ Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Sinocare, Inc.. It received FDA 510(k) clearance on 2023-12-01 under 510(k) number K231476. 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 TRUENESS™ AIR Blood Glucose Monitoring System; TRUENESS™ Blood Glucose Monitoring System?

TRUENESS™ AIR Blood Glucose Monitoring System; TRUENESS™ Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2023-12-01. The listed applicant is Sinocare, Inc.. The 510(k) number is K231476.

When did TRUENESS™ AIR Blood Glucose Monitoring System; TRUENESS™ Blood Glucose Monitoring System receive FDA 510(k) clearance?

TRUENESS™ AIR Blood Glucose Monitoring System; TRUENESS™ Blood Glucose Monitoring System received FDA 510(k) clearance on 2023-12-01, under 510(k) number K231476.

Who is the listed applicant for TRUENESS™ AIR Blood Glucose Monitoring System; TRUENESS™ Blood Glucose Monitoring System?

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

What is the FDA product code for TRUENESS™ AIR Blood Glucose Monitoring System; TRUENESS™ Blood Glucose Monitoring System?

The FDA product code for TRUENESS™ AIR Blood Glucose Monitoring System; TRUENESS™ 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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