510(k) K813562

SYRINGE DRIVER 209 by Medix Medical Electronics (U.S.A.), Inc. — Product Code FRN

K813562 is an FDA 510(k) premarket notification submitted by Medix Medical Electronics (U.S.A.), Inc. for the device "SYRINGE DRIVER 209". The FDA issued a decision of Substantially Equivalent on February 1, 1982. 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
February 1, 1982
Date Received
December 22, 1981
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