510(k) K910934

FLO-GARD 6300 DUAL CHANNEL VOLUMETRIC INFUSION PUM by Baxter Healthcare Corp — Product Code FRN

K910934 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "FLO-GARD 6300 DUAL CHANNEL VOLUMETRIC INFUSION PUM". The FDA issued a decision of Substantially Equivalent on Jun 24, 1991. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Baxter Healthcare Corp has 507 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Jun 24, 1991
Date Received
Mar 6, 1991
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
510(k)

Source: FDA 510(k) database entry for K910934. Report a data issue: hello@regdatalab.com.