FDA 510(k) Application Details - K090736

Device Classification Name Pump, Infusion

  More FDA Info for this Device
510(K) Number K090736
Device Name Pump, Infusion
Applicant ZOLL MEDICAL CORPORATION
269 MILL ROAD
CHELMSFORD, MA US
Other 510(k) Applications for this Company
Contact EILEEN M BOYLE
Other 510(k) Applications for this Contact
Regulation Number 880.5725

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

  More FDA Info for this Product Code
Date Received 03/19/2009
Decision Date 05/20/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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