510(k) K002739

INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K by Baxter Healthcare Corp — Product Code MEA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 2000
Date Received
September 1, 2000
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion, Pca
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type