SENTINEL ENTERAL FEEDING PUMP, LH2001 ENTERAL FEEDING PUMP— 510(k) K011587

Substantially Equivalent

Entracon Corp.

FDA 510(k) clearance K011587 for SENTINEL ENTERAL FEEDING PUMP, LH2001 ENTERAL FEEDING PUMP, Substantially Equivalent on 2001-06-01. Applicant: Entracon Corp..

Clearance details

Applicant: Entracon Corp.
Product code: Code LZH
Advisory panel: General Hospital
Date received: 2001-05-23
Decision date: 2001-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Foxborough, MA, 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.