510(k) K002679

6060 MULTI-THERAPY PUMP, MODEL 2M9832; 6060 EPIDURAL PUMP, MODEL 2L9351 by Baxter Healthcare Corp — Product Code FRN

K002679 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "6060 MULTI-THERAPY PUMP, MODEL 2M9832; 6060 EPIDURAL PUMP, MODEL 2L9351". The FDA issued a decision of Substantially Equivalent on Sep 18, 2000. 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
Sep 18, 2000
Date Received
Aug 28, 2000
Clearance Type
Special
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 K002679. Report a data issue: hello@regdatalab.com.