510(k) K041738

BAXTER INFUSOR SV (SMALL VOLUME); BAXTER INFUSOR LV (LARGE VOLUME) by Baxter Healthcare Corporation — Product Code FRN

K041738 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corporation for the device "BAXTER INFUSOR SV (SMALL VOLUME); BAXTER INFUSOR LV (LARGE VOLUME)". The FDA issued a decision of Substantially Equivalent on Jul 9, 2004. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Baxter Healthcare Corporation has 60 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Jul 9, 2004
Date Received
Jun 28, 2004
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 K041738. Report a data issue: hello@regdatalab.com.