510(k) K841512

ETHOX RELIA-FLO 2001 ENTERAL FEED by Ethox Corp. — Product Code FRN

K841512 is an FDA 510(k) premarket notification submitted by Ethox Corp. for the device "ETHOX RELIA-FLO 2001 ENTERAL FEED". The FDA issued a decision of Substantially Equivalent on May 21, 1984. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Ethox Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 1984
Date Received
April 12, 1984
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