FDA 510(k) Application Details - K060123

Device Classification Name Monitor, Electric For Gravity Flow Infusion Systems

  More FDA Info for this Device
510(K) Number K060123
Device Name Monitor, Electric For Gravity Flow Infusion Systems
Applicant SMITH & NEPHEW, INC.
150 MINUTEMAN RD.
ANDOVER, MA 01810 US
Other 510(k) Applications for this Company
Contact JANICE HASELTON
Other 510(k) Applications for this Contact
Regulation Number 880.2420

  More FDA Info for this Regulation Number
Classification Product Code FLN
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 01/18/2006
Decision Date 02/14/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact