ENTERALITE INFINITY ENTERAL FEEDING PUMP— 510(k) K031199

Substantially Equivalent

Zevex Intl., Inc.

FDA 510(k) clearance K031199 for ENTERALITE INFINITY ENTERAL FEEDING PUMP, Substantially Equivalent on 2003-07-09. Applicant: Zevex Intl., Inc..

Clearance details

Applicant: Zevex Intl., Inc.
Product code: Code LZH
Advisory panel: General Hospital
Date received: 2003-04-14
Decision date: 2003-07-09
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, 2020-01-01 through 2026-04-23. 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.