DeviceClearance

K253516

Substantially Equivalent

Assert-IQ (DM5100)

Applicant
ABBOTT MEDICAL
Product code
MXD
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Sylmar, CA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code MXD

product code MXD
Injury
1,880
Malfunction
9,487
Total
11,367

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.