ENTERALITE INFINITY ENTERAL FEEDING PUMP— 510(k) K031199
Substantially EquivalentZevex Intl., Inc.
FDA 510(k) clearance K031199 for ENTERALITE INFINITY ENTERAL FEEDING PUMP, Substantially Equivalent on 2003-07-09. Applicant: Zevex Intl., Inc.. Device class: 2.
Clearance details
- Applicant
- Zevex Intl., Inc.
- Product code
- Code LZH
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code LZH
view allMore clearances from Zevex Intl., Inc.
view allAdverse 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 →
Recalls naming K031199
K-number listed on FDA's recall record- Z-0294-2013 — EnteraLite Infinity Enteral Feeding Pump identified with the following list numbers: INFKIT2 and INFORNG. The device is used with disposable PVC administration tubing sets to provide a means for the volumetric delivery of fluids used in enteral applications. The EnteraLite Infinity enteral feeding pump with disposable PVC administration tubing sets and user accessories provide a means for the volumetric delivery of fluids used in enteral applications.
- Z-0764-2013 — Infinity Enteralite Ambulatory Feeding Pumps, List number: INFKIT2 - Addendum to Operator's Manual Product usage: provide a means for the volumetric delivery of fluids used in Enteral applications.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K031199.
Data sourced from openFDA. This site is unofficial and independent of the FDA.