The following data is part of a premarket notification filed by Zevex, Inc. with the FDA for Enteralite Infinity Enteral Pump Delivery Set, 1200 Ml Enteral Feeding Delivery Set.
| Device ID | K142539 |
| 510k Number | K142539 |
| Device Name: | EnteraLite Infinity Enteral Pump Delivery Set, 1200 ML Enteral Feeding Delivery Set |
| Classification | Gastrointestinal Tubes With Enteral Specific Connectors |
| Applicant | ZEVEX, INC. 4314 ZEVEX PARK LN. Salt Lake City, UT 84123 |
| Contact | Dianne Batch |
| Correspondent | Dianne Batch ZEVEX, INC. 4314 ZEVEX PARK LN. Salt Lake City, UT 84123 |
| Product Code | PIF |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-09 |
| Decision Date | 2015-01-08 |
| Summary: | summary |