510(k) K253558

Luminoah FLOW™ Enteral Nutrition System by Luminoah — Product Code LZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 2026
Date Received
November 17, 2025
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