510(k) K863864

AMBULATORY INFUSION PUMP, MODEL AS30C by Travenol Laboratories, S.A. — Product Code FRN

K863864 is an FDA 510(k) premarket notification submitted by Travenol Laboratories, S.A. for the device "AMBULATORY INFUSION PUMP, MODEL AS30C". The FDA issued a decision of Substantially Equivalent on February 4, 1987. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Travenol Laboratories, S.A. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1987
Date Received
October 3, 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