510(k) clearance

Electronic Blood Pressure Monitor (BP-204C, BP-204A, BP-215, BP-203C, BP-205A, BP-201C, BP-217, BP-202C, BP-202 BP-205, BP-205B,BP-206)

FDA 510(k) source

510(k) number

K260470

Applicant

Shenzhen Brav Electronic Technologies Co., Ltd.

Decision date

Oct 1, 2026

Date received

Feb 12, 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

Shenzhen, CN