510(k) K031199

ENTERALITE INFINITY ENTERAL FEEDING PUMP by Zevex Intl., Inc. — Product Code LZH

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