FDA 510(k) Application Details - K031199

Device Classification Name Pump, Infusion, Enteral

  More FDA Info for this Device
510(K) Number K031199
Device Name Pump, Infusion, Enteral
Applicant ZEVEX INTL., INC.
16787 BERNARDO CENTER DR.
SUITE A-1
SAN DIEGO, CA 92128 US
Other 510(k) Applications for this Company
Contact SEAN M CURRY
Other 510(k) Applications for this Contact
Regulation Number 880.5725

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

  More FDA Info for this Product Code
Date Received 04/14/2003
Decision Date 07/09/2003
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