510(k) K894506

ENTERA-FLO ENTERAL FEEDING PUMP by Delmed, Inc. — Product Code FRN

K894506 is an FDA 510(k) premarket notification submitted by Delmed, Inc. for the device "ENTERA-FLO ENTERAL FEEDING PUMP". The FDA issued a decision of Substantially Equivalent on August 6, 1990. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Delmed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 1990
Date Received
July 19, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type