DeviceClearance

K031199

Substantially Equivalent

ENTERALITE INFINITY ENTERAL FEEDING PUMP

Applicant
Zevex Intl., Inc.
Product code
LZH
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Diego, CA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code LZH

product code LZH
Death
12
Malfunction
4,186
Total
4,198

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.