510(k) K861040

ENTERNAL INFUSER MULTIPUMP 203 by Medix Medical Electronics (U.S.A.), Inc. — Product Code FRN

K861040 is an FDA 510(k) premarket notification submitted by Medix Medical Electronics (U.S.A.), Inc. for the device "ENTERNAL INFUSER MULTIPUMP 203". The FDA issued a decision of Substantially Equivalent on June 23, 1986. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Medix Medical Electronics (U.S.A.), Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 1986
Date Received
March 18, 1986
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