510(k) K895428— A&D AUTOMATIC DIGITAL BLOOD PRESSURE METER 2510/20

Substantially Equivalent

A&D Engineering, Inc.

Clearance details

Applicant: A&D Engineering, Inc.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 1989-09-05
Decision date: 1989-11-28
Decision: Substantially Equivalent
Clearance type: Traditional
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.