FDA 510(k)

Finetest Lite Smart Blood Glucose Monitoring System

K-Number: K201396 · 2020-10-16

Decision Date2020-10-16

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

Finetest Lite Smart Blood Glucose Monitoring System is a medical device manufactured by Osang Healthcare Co. , Ltd.. It received FDA 510(k) clearance on 2020-10-16 under approval number K201396. 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 Finetest Lite Smart Blood Glucose Monitoring System?

Finetest Lite Smart Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2020-10-16. It is manufactured by Osang Healthcare Co. , Ltd.. The 510(k) number is K201396.

When was Finetest Lite Smart Blood Glucose Monitoring System approved by the FDA?

Finetest Lite Smart Blood Glucose Monitoring System received FDA 510(k) clearance on 2020-10-16, under approval number K201396.

What company makes Finetest Lite Smart Blood Glucose Monitoring System?

Finetest Lite Smart Blood Glucose Monitoring System is manufactured by Osang Healthcare Co. , Ltd..

What is the FDA product code for Finetest Lite Smart Blood Glucose Monitoring System?

The FDA product code for Finetest Lite Smart Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.

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Related PubMed Literature

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Other Devices by Osang Healthcare Co. , Ltd.

K182286Oh'Care Lite Smart Blood Glucose Monitoring System K203562Finetest Lite Blood Glucose Monitoring System

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Official Source

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