510(k) K840823

TREONIC C30 by Vickers America Medical Corp. — Product Code LDR

K840823 is an FDA 510(k) premarket notification submitted by Vickers America Medical Corp. for the device "TREONIC C30". The FDA issued a decision of Substantially Equivalent on March 23, 1984. The device falls under product code LDR (Controller, Infusion, Intravascular, Electronic), 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
March 23, 1984
Date Received
February 24, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Controller, Infusion, Intravascular, Electronic
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type