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FDA 510(k)

Livongo Blood Glucose Monitoring System (BG1000)

K-Number: K200277 · 2020-06-04

ApplicantLivongo Health, Inc.
Decision Date2020-06-04
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Livongo Blood Glucose Monitoring System (BG1000) is a medical device manufactured by Livongo Health, Inc.. It received FDA 510(k) clearance on 2020-06-04 under approval 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.

Frequently Asked Questions

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. It is manufactured by Livongo Health, Inc.. The 510(k) number is K200277.

When was Livongo Blood Glucose Monitoring System (BG1000) approved by the FDA?

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

What company makes Livongo Blood Glucose Monitoring System (BG1000)?

Livongo Blood Glucose Monitoring System (BG1000) is manufactured by Livongo Health, Inc..

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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Related PubMed Literature

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Official Source

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