DeviceClearance

K062449

Substantially Equivalent

EMPOWERMR INJECTOR SYSTEM, MODEL 9730

Applicant
E-Z-Em, Inc.
Product code
IZQ
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Abbreviated
Location
Westbury, NY, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code IZQ

product code IZQ
Death
7
Total
7

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.