510(k) K982640

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

K982640 is an FDA 510(k) premarket notification submitted by Medex, Inc. for the device "MEDEX 3000 SERIES SYRINGE INFUSION PUMP". The FDA issued a decision of ST on April 6, 1999. 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
ST ()
Decision Date
April 6, 1999
Date Received
July 29, 1998
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