FDA 510(k) Application Details - K992038

Device Classification Name Nebulizer (Direct Patient Interface)

  More FDA Info for this Device
510(K) Number K992038
Device Name Nebulizer (Direct Patient Interface)
Applicant FERRARIS MEDICAL, INC.
555 THIRTEENTH STREET, N.W.
WASHINGTON, DC US
Other 510(k) Applications for this Company
Contact JONATHAN S KAHAN
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 06/16/1999
Decision Date 09/09/1999
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 N
Expedited Review



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