FDA 510(k)

TRUE METRIX Self Monitoring Blood Glucose System

Número K: K262116 · 2026-07-23

Data da decisão2026-07-23

Código do produtoNBW

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

TRUE METRIX Self Monitoring Blood Glucose System is the device name listed in this FDA 510(k) record. The listed applicant is Trividia Health, Inc.. It received FDA 510(k) clearance on 2026-07-23 under 510(k) number K262116. 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.

Perguntas frequentes

What is the TRUE METRIX Self Monitoring Blood Glucose System?

TRUE METRIX Self Monitoring Blood Glucose System is a medical device that received FDA 510(k) clearance on 2026-07-23. The listed applicant is Trividia Health, Inc.. The 510(k) number is K262116.

When did TRUE METRIX Self Monitoring Blood Glucose System receive FDA 510(k) clearance?

TRUE METRIX Self Monitoring Blood Glucose System received FDA 510(k) clearance on 2026-07-23, under 510(k) number K262116.

Who is the listed applicant for TRUE METRIX Self Monitoring Blood Glucose System?

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

What is the FDA product code for TRUE METRIX Self Monitoring Blood Glucose System?

The FDA product code for TRUE METRIX Self Monitoring Blood Glucose System is NBW. This falls under the OB/GYN category.

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Outros registros que listam Trividia Health, Inc. como candidato(a)

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Dispositivos Relacionados (Código: NBW)

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