510(k) K031199
K031199 is an FDA 510(k) premarket notification submitted by Zevex Intl., Inc. for the device "ENTERALITE INFINITY ENTERAL FEEDING PUMP". The FDA issued a decision of Substantially Equivalent on July 9, 2003. The device falls under product code LZH (Pump, Infusion, Enteral), a Class II device regulated under 21 CFR 880.5725. Zevex Intl., Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 9, 2003
- Date Received
- April 14, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Infusion, Enteral
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- HO
- Submission Type