510(k) K040899

MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP by Medex, Inc. — Product Code FRN

K040899 is an FDA 510(k) premarket notification submitted by Medex, Inc. for the device "MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP". The FDA issued a decision of Substantially Equivalent on April 30, 2004. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Medex, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 2004
Date Received
April 6, 2004
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