FDA 510(k)

Oh'Care Lite Smart Blood Glucose Monitoring System

K-Number: K182286 · 2018-09-19

Decision Date2018-09-19

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

Oh'Care Lite Smart Blood Glucose Monitoring System is a medical device manufactured by Osang Healthcare Co. , Ltd.. It received FDA 510(k) clearance on 2018-09-19 under approval number K182286. 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 Oh'Care Lite Smart Blood Glucose Monitoring System?

Oh'Care Lite Smart Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2018-09-19. It is manufactured by Osang Healthcare Co. , Ltd.. The 510(k) number is K182286.

When was Oh'Care Lite Smart Blood Glucose Monitoring System approved by the FDA?

Oh'Care Lite Smart Blood Glucose Monitoring System received FDA 510(k) clearance on 2018-09-19, under approval number K182286.

What company makes Oh'Care Lite Smart Blood Glucose Monitoring System?

Oh'Care Lite Smart Blood Glucose Monitoring System is manufactured by Osang Healthcare Co. , Ltd..

What is the FDA product code for Oh'Care Lite Smart Blood Glucose Monitoring System?

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

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Other Devices by Osang Healthcare Co. , Ltd.

K201396Finetest 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.