510(k) clearance

Upper Arm Blood pressure monitor (BP7155D)

FDA 510(k) source

510(k) number

K261929

Applicant

OMRON Healthcare, Inc.

Decision date

Sep 10, 2026

Date received

Jun 9, 2026

Decision

Substantially Equivalent

Clearance type

Special

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

Hoffman Estates, IL, US