K250231

Automatic Upper Arm Blood Pressure Monitor (BA-831X, BA-832X, BA-833X, BA-837X, BA-838X, BA-842X, BA-843X, BA-845X, BA-847X, BA-849X, BA-851X, BA-852X, BA-855X, BA-835, BA-836, BA-839, BA-840, BA-856)

510(k) number: K250231
Device name: Automatic Upper Arm Blood Pressure Monitor (BA-831X, BA-832X, BA-833X, BA-837X, BA-838X, BA-842X, BA-843X, BA-845X, BA-847X, BA-849X, BA-851X, BA-852X, BA-855X, BA-835, BA-836, BA-839, BA-840, BA-856)
Applicant: Dongguan E-Test Technology Co., Ltd. CN
Product code: DXN — System, Measurement, Blood-Pressure, Non-Invasive
Decision date: 2025-09-03
Date received: 2025-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Cardiovascular

PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain

Also available from FDA: K250231.pdf

Official FDA record: K250231

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.