510(k) K790945

MODEL 113 TREONIC IP3 DIGITAL SYRINGE PU by Vickers America Medical Corp. — Product Code FRN

K790945 is an FDA 510(k) premarket notification submitted by Vickers America Medical Corp. for the device "MODEL 113 TREONIC IP3 DIGITAL SYRINGE PU". The FDA issued a decision of Substantially Equivalent on June 1, 1979. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Vickers America Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 1979
Date Received
May 18, 1979
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