510(k) clearance

Automatic Digital Blood Pressure monitor (LD-526)

FDA 510(k) source

510(k) number

K262658

Applicant

Honsun (Nantong) Co., Ltd.

Decision date

Aug 31, 2026

Date received

Jul 30, 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

Nantong, CN