510(k) K050107

HARVARD 2 SYRINGE PUMP, MODEL 2001-001 by Harvard Clinical Technology — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 2005
Date Received
January 18, 2005
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