510(k) clearance

Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus)

FDA 510(k) source

510(k) number

K261394

Applicant

JOYTECH Healthcare Co., Ltd.

Decision date

Aug 26, 2026

Date received

Apr 29, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

DXN

Device type

System, Measurement, Blood-Pressure, Non-Invasive

Device class

Class II

Regulation

21 CFR 870.1130

Advisory committee

Cardiovascular

Statement or summary

Summary

Third party

N

Location

Hangzhou, CN