DeviceClearance

K212168

Substantially Equivalent

A&D Medical UM-212BLE Blood Pressure Monitor

Applicant
A&D Company, Ltd.
Product code
DXN
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Jose, CA, US
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, 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.