The following data is part of a premarket notification filed by Zevex, Inc. with the FDA for Enteralite Infinity Spike Enteral Delivery Set; Enteralite Infinity 500 Ml Bag Enteral Delivery Set;.
| Device ID | K131154 |
| 510k Number | K131154 |
| Device Name: | ENTERALITE INFINITY SPIKE ENTERAL DELIVERY SET; ENTERALITE INFINITY 500 ML BAG ENTERAL DELIVERY SET; |
| Classification | Pump, Infusion, Enteral |
| Applicant | ZEVEX, INC. 4314 ZEVEX PARK LN. Salt Lake City, UT 84123 |
| Contact | Niloufar Samimi |
| Correspondent | Niloufar Samimi ZEVEX, INC. 4314 ZEVEX PARK LN. Salt Lake City, UT 84123 |
| Product Code | LZH |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-24 |
| Decision Date | 2014-02-12 |
| Summary: | summary |