510(k) K870801

FLO-GARD 6200 VOLUMETRIC INFUSION/PUMPING BLOOD by Travenol Laboratories, S.A. — Product Code FRN

K870801 is an FDA 510(k) premarket notification submitted by Travenol Laboratories, S.A. for the device "FLO-GARD 6200 VOLUMETRIC INFUSION/PUMPING BLOOD". The FDA issued a decision of Substantially Equivalent on September 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
September 4, 1987
Date Received
February 27, 1987
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