ENTERALITE INFINITY ENTERAL FEEDING PUMP
FDA 510(k) clearance K031199 · decided 2003-07-09
Clearance details
- K-number
- K031199
- Device name
- ENTERALITE INFINITY ENTERAL FEEDING PUMP
- Applicant
- Zevex Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-04-14
- Decision date
- 2003-07-09
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- LZH
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Infinity Enteralite Ambulatory Feeding Pumps, List number: INFKIT2 - Addendum to Operator' recall (Z-0764-2013) | MOOG Medical Devices Group | 2013-01-31 |
| EnteraLite Infinity Enteral Feeding Pump identified with the following list numbers: INFKI recall (Z-0294-2013) | MOOG Medical Devices Group | 2012-11-15 |
| EnteraLite Infinity Enteral Feeding Pump, REF INFP01, Zevex Enteral Nutrition Delivery Sys recall (Z-2112-2009) | Zevex International, Inc. | 2009-09-21 |
| Infinity Orange Enteral Feeding Pump, REF INFORNG, Zevex Enteral Nutrition Delivery System recall (Z-2113-2009) | Zevex International, Inc. | 2009-09-21 |