510(k) K002739

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

K002739 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K". The FDA issued a decision of Substantially Equivalent on September 11, 2000. The device falls under product code MEA (Pump, Infusion, Pca), a Class II device regulated under 21 CFR 880.5725. Baxter Healthcare Corp has at least 10 other 510(k) clearances on record.

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