510(k) K042967— A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODELS UB-511 & UB-512

Substantially Equivalent

A&D Engineering, Inc.

Clearance details

Applicant: A&D Engineering, Inc.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2004-10-28
Decision date: 2004-12-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Milpitas, CA, US

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.