510(k) K891289

FLO-GARD 6300 DUAL CHANNEL VOLUME INFUSION PUMP by Baxter Healthcare Corp — Product Code FRN

K891289 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "FLO-GARD 6300 DUAL CHANNEL VOLUME INFUSION PUMP". The FDA issued a decision of Substantially Equivalent on Feb 2, 1990. 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
Feb 2, 1990
Date Received
Mar 10, 1989
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 K891289. Report a data issue: hello@regdatalab.com.