510(k) clearance

EASYMAX Voice Blood Glucose Monitoring System

FDA 510(k) source

510(k) number

K261293

Applicant

EPS Bio Technology Corp.

Decision date

Oct 23, 2026

Date received

Apr 20, 2026

Decision

Substantially Equivalent

Clearance type

Special

Product code

NBW

Device type

System, Test, Blood Glucose, Over The Counter

Device class

Class II

Regulation

21 CFR 862.1345

Advisory committee

Clinical Chemistry

Statement or summary

Summary

Third party

N

Location

Hsinchu, TW