510(k) K954735
K954735 is an FDA 510(k) premarket notification submitted by Zevex Intl., Inc. for the device "ENTERALITE". The FDA issued a decision of ST on April 15, 1996. 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
- ST ()
- Decision Date
- April 15, 1996
- Date Received
- October 16, 1995
- 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