FDA 510(k)

Livongo Blood Glucose Monitoring System (BG1000)

N.º K: K200277 · 2020-06-04

Fecha de decisión2020-06-04

Código de productoNBW

Comité asesorCH

DecisiónSubstantially Equivalent

Resumen del dispositivo

Livongo Blood Glucose Monitoring System (BG1000) is the device name listed in this FDA 510(k) record. The listed applicant is Livongo Health, Inc.. It received FDA 510(k) clearance on 2020-06-04 under 510(k) number K200277. 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 Livongo Blood Glucose Monitoring System (BG1000)?

Livongo Blood Glucose Monitoring System (BG1000) is a medical device that received FDA 510(k) clearance on 2020-06-04. The listed applicant is Livongo Health, Inc.. The 510(k) number is K200277.

When did Livongo Blood Glucose Monitoring System (BG1000) receive FDA 510(k) clearance?

Livongo Blood Glucose Monitoring System (BG1000) received FDA 510(k) clearance on 2020-06-04, under 510(k) number K200277.

Who is the listed applicant for Livongo Blood Glucose Monitoring System (BG1000)?

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

What is the FDA product code for Livongo Blood Glucose Monitoring System (BG1000)?

The FDA product code for Livongo Blood Glucose Monitoring System (BG1000) is NBW. This falls under the OB/GYN category.

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