510(k) K990259

DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM by Disetronic Medical Systems — Product Code FRN

K990259 is an FDA 510(k) premarket notification submitted by Disetronic Medical Systems for the device "DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM". The FDA issued a decision of Substantially Equivalent on February 12, 1999. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Disetronic Medical Systems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1999
Date Received
January 27, 1999
Clearance Type
Special
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