A & D MEDICAL LIFESOURCE UA-704 DIGITAL BLOOD PRESSURE MONITORS— 510(k) K032499

Substantially Equivalent

A&D Engineering, Inc.

FDA 510(k) clearance K032499 for A & D MEDICAL LIFESOURCE UA-704 DIGITAL BLOOD PRESSURE MONITORS, Substantially Equivalent on 2003-10-30. Applicant: A&D Engineering, Inc..

Clearance details

Applicant
A&D Engineering, Inc.
Product code
Code DXN
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Milpitas, CA, US
Download summary PDFView 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, through . 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.