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FDA 510(k)

Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB

K-Number: K190564 · 2019-06-02

ApplicantBionime Corporation
Decision Date2019-06-02
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB is a medical device manufactured by Bionime Corporation. It received FDA 510(k) clearance on 2019-06-02 under approval number K190564. 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 Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB?

Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB is a medical device that received FDA 510(k) clearance on 2019-06-02. It is manufactured by Bionime Corporation. The 510(k) number is K190564.

When was Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB approved by the FDA?

Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB received FDA 510(k) clearance on 2019-06-02, under approval number K190564.

What company makes Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB?

Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB is manufactured by Bionime Corporation.

What is the FDA product code for Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB?

The FDA product code for Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB is NBW. This falls under the OB/GYN category.

Related Clinical Trials

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Related PubMed Literature

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Other Devices by Bionime Corporation

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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