FRENTA II+ ENTERAL FEEDING PUMP— 510(k) K914216

Substantially Equivalent

Fresenius Pharma

FDA 510(k) clearance K914216 for FRENTA II+ ENTERAL FEEDING PUMP, Substantially Equivalent on 1992-03-18. Applicant: Fresenius Pharma.

Clearance details

Applicant: Fresenius Pharma
Product code: Code LZH
Advisory panel: General Hospital
Date received: 1991-09-19
Decision date: 1992-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Brunswick, NJ, US

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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.