Easyplus Mini R13N Self Monitoring Blood Glucose System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K091481 FDA 510(k)
- FDA Product Code
- NBW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1345 FDA 510(k)
- Regulation Number
- 862.1345 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Easyplus Mini R13n Self Monitoring Blood Glucose System is a self-monitoring blood glucose system. It is designed to help users monitor their blood glucose levels on a regular basis.
The system is supplied with a user manual and is intended for self-monitoring of blood glucose. It has received FDA 510K authorization. The device is used for running blood glucose tests with blood from fingertips and has features such as setting the time and date, and running a control solution test.
Frequently asked questions
What is the Easyplus Mini R13n Blood Glucose System used for?
The Easyplus Mini R13n is a self-monitoring blood glucose system designed to help users regularly monitor their blood glucose levels using blood samples from fingertips.
What features does the Easyplus Mini R13n Blood Glucose System include?
The system includes features for setting the time and date, running control solution tests, and is supplied with a user manual to assist with proper usage and blood glucose monitoring.
What is the regulatory status of the Easyplus Mini R13n Blood Glucose System?
The Easyplus Mini R13n Blood Glucose System has received FDA 510K authorization, which means it has been determined to be substantially equivalent to other legally marketed devices.
How is the Easyplus Mini R13n Blood Glucose System supplied?
The system is supplied with a user manual to guide users on proper operation and blood glucose testing procedures.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: EPS Bio Technology EasyPlus mini R13N User Manual, Eps bio technology EasyPlus mini R13N Manuals | ManualsLib, EPS Bio Technology EasyPlus mini : User`s manual
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K091481 | Class II | Active |
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Manufacturer
- Manufacturer
- Eps Bio Technology Corp.
Sources (1)
- FDA 510(k) K091481 24 fields · synced Oct 6, 2026