BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software— 510(k) K173028

Substantially Equivalent

Healthstats International Pte. , Ltd.

FDA 510(k) clearance K173028 for BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software, Substantially Equivalent on 2018-06-21. Applicant: Healthstats International Pte. , Ltd..

Clearance details

Applicant: Healthstats International Pte. , Ltd.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2017-09-28
Decision date: 2018-06-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Singapore, SG

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXN

product code DXN

Death: 3
Injury: 169
Malfunction: 1,019
Other: 2
Total: 1,193

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.