The following data is part of a premarket notification filed by Zevex Intl., Inc. with the FDA for Enteralite Infinity Enteral Feeding Pump.
| Device ID | K031199 |
| 510k Number | K031199 |
| Device Name: | ENTERALITE INFINITY ENTERAL FEEDING PUMP |
| Classification | Pump, Infusion, Enteral |
| Applicant | ZEVEX INTL., INC. 16787 BERNARDO CENTER DR. SUITE A-1 San Diego, CA 92128 |
| Contact | Sean M Curry |
| Correspondent | Sean M Curry ZEVEX INTL., INC. 16787 BERNARDO CENTER DR. SUITE A-1 San Diego, CA 92128 |
| Product Code | LZH |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-14 |
| Decision Date | 2003-07-09 |
| Summary: | summary |