FDA 510(k) Application Details - K041418

Device Classification Name Nebulizer (Direct Patient Interface)

  More FDA Info for this Device
510(K) Number K041418
Device Name Nebulizer (Direct Patient Interface)
Applicant Cardinal Health
1500 WAUKEGAN ROAD
MCGAW PARK, IL 60085 US
Other 510(k) Applications for this Company
Contact LAVENIA FORD
Other 510(k) Applications for this Contact
Regulation Number 868.5630

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

  More FDA Info for this Product Code
Date Received 05/27/2004
Decision Date 06/10/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review



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