510(k) K933652

FREEDOM 60 SYRINGE INFUSION PUMP SYSTEM WITH SYRINGE SET & TUBING by Repro-Med Systems, Inc. — Product Code FRN

K933652 is an FDA 510(k) premarket notification submitted by Repro-Med Systems, Inc. for the device "FREEDOM 60 SYRINGE INFUSION PUMP SYSTEM WITH SYRINGE SET & TUBING". The FDA issued a decision of ST on May 18, 1994. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Repro-Med Systems, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
ST ()
Decision Date
May 18, 1994
Date Received
July 28, 1993
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