K803249

Substantially Equivalent

FLUID WARMER

Applicant
Datachem, Inc.
Product code
LGZ
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code LGZ

product code LGZ
Death
16
Malfunction
5,916
Other
1
Total
5,933

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.